Quick answers
- What is Chlorpromazine hydrochloride used for?
- The FDA-approved label (Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, May 12, 2026) says: “For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Chlorpromazine hydrochloride?
- The “Adverse Reactions” section of the FDA label (Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, May 12, 2026) begins: “Note: Some adverse effects of chlorpromazine may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses. Drowsiness: Usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Chlorpromazine hydrochloride have a boxed warning?
- Yes. The FDA label for Chlorpromazine Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Chlorpromazine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Chlorpromazine hydrochloride been recalled?
- FDA enforcement reports list 24 recalls of products of this medicine; the newest started September 3, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Chlorpromazine hydrochloride?
- 31 companies list prescription products of Chlorpromazine hydrochloride in the FDA NDC Directory, including Remedyrepack Inc., American Health Packaging and Zydus Lifesciences Limited.
What Chlorpromazine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. …
— FDA label: Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, effective May 12, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC; it covers 5 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 40 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
38 of 40 FDA labels for this medicine have a boxed warning.
Chlorpromazine hydrochloride boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.
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Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
— FDA label: Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, effective May 12, 2026. Read the full label on DailyMed →
Chlorpromazine hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Note: Some adverse effects of chlorpromazine may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses. Drowsiness: Usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered.
Read more of this section
Jaundice: Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported. There is no conclusive evidence that pre-existing liver disease makes patients more susceptible to jaundice. Alcoholics with cirrhosis have been successfully treated with chlorpromazine without complications. Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have experienced jaundice with a phenothiazine should not, if possible, be reexposed to chlorpromazine or other phenothiazines. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. Liver function tests in jaundice induced by the drug may mimic extrahepatic obstruction; withhold exploratory laparotomy until extrahepatic obstruction is confirmed. Hematological Disorders: including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia have been reported. Agranulocytosis – Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy. Most cases have occurred between the fourth and tenth weeks of therapy; patients should be watched closely during that period. Moderate suppression of white blood cells is not an indication for stopping treatment unless accompanied by the symptoms described above. Cardiovascular: Hypotensive Effects – Postural hypotension, simple tachycardia, momentary fainting and dizziness may occur rarely, after the first oral dose. Usually recovery is spontaneous and symptoms disappear within ½ to 2 hours. Occasionally, these effects may be more severe and prolonged, producing a shock-like condition. To control hypotension, place patient in head–low position with legs raised. If a vasoconstrictor is required, norepinephrine and phenylephrine are the most suitable. Other pressor agents, including epinephrine, should not be used as they may cause a paradoxical further lowering of blood pressure. EKG Changes – particularly nonspecific, usually reversible Q and T wave distortions - have been observed in some patients receiving phenothiazine tranquilizers, including chlorpromazine. Note: Sudden death, apparently due to cardiac arrest, has been reported.
— FDA label: Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, effective May 12, 2026. This is part of the section. Read the full label on DailyMed →
Chlorpromazine hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
–ADULTS Adjust dosage to individual and the severity of his condition, recognizing that the milligram for milligram potency relationship among all dosage forms has not been precisely established clinically. It is important to increase dosage until symptoms are controlled. Dosage should be increased more gradually in debilitated or emaciated patients.
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In continued therapy, gradually reduce dosage to the lowest effective maintenance level, after symptoms have been controlled for a reasonable period. The 100 mg and 200 mg tablets are for use in severe neuropsychiatric conditions. Elderly Patients – In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients. Psychotic Disorders – Increase dosage gradually until symptoms are controlled. Maximum improvement may not be seen for weeks or even months. Continue optimum dosage for 2 weeks; then gradually reduce dosage to the lowest effective maintenance level. Daily dosage of 200 mg is not unusual. Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients). Hospitalized Patients: Acute Schizophrenic or Manic States – It is recommended that initial treatment be with chlorpromazine hydrochloride injection until patient is controlled. Usually patient becomes quiet and co-operative within 24 to 48 hours and oral doses may be substituted and increased until the patient is calm. 500 mg a day is generally sufficient. While gradual increases to 2,000 mg a day or more may be necessary, there is usually little therapeutic gain to be achieved by exceeding 1,000 mg a day for extended periods. In general, dosage levels should be lower in the elderly, the emaciated and the debilitated. Less Acutely Disturbed – 25 mg t.i.d. Increase gradually until effective dose is reached – usually 400 mg daily. Outpatients – 10 mg t.i.d. or q.i.d., or 25 mg b.i.d. or t.i.d. More Severe Cases – 25 mg t.i.d. After 1 or 2 days, daily dosage may be increased by 20 to 50 mg at semi-weekly intervals until patient becomes calm and cooperative. Prompt Control of Severe Symptoms – Initial treatment should be with intramuscular chlorpromazine. Subsequent doses should be oral, 25 mg to 50 mg t.i.d. Nausea and Vomiting – 10 mg to 25 mg q4 to 6h, p.r.n., increased, if necessary. Presurgical Apprehension – 25 mg to 50 mg, 2 to 3 hours before the operation. Intractable Hiccups – 25 mg to 50 mg t.i.d. or q.i.d. If symptoms persist for 2 to 3 days, parenteral therapy is indicated. Acute Intermittent Porphyria – 25 mg to 50 mg t.i.d. or q.i.d. Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients.
— FDA label: Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, effective May 12, 2026. Read the full label on DailyMed →
When Chlorpromazine hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc).
— FDA label: Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, effective May 12, 2026. Read the full label on DailyMed →
Chlorpromazine hydrochloride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
(See also ADVERSE REACTIONS.) Symptoms Primarily symptoms of central nervous system depression to the point of somnolence or coma. Hypotension and extrapyramidal symptoms. Other possible manifestations include agitation and restlessness, convulsions, fever, autonomic reactions such as dry mouth and ileus. EKG changes and cardiac arrhythmias.
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Treatment It is important to determine other medications taken by the patient since multiple drug therapy is common in over dosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe over dosage. Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus. Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates, or diphenhydramine hydrochloride. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression. If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended. Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided. If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable to administer a vasoconstrictor, norepinephrine and phenylephrine are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating action of these agents and cause a further lowering of blood pressure. Limited experience indicates that phenothiazines are not dialyzable.
— FDA label: Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, effective May 12, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, sugar coated · Injection · Tablet · Tablet, coated · Concentrate |
|---|---|
| Route | Oral · Intramuscular |
| Prescription products | 121 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| chlorpromazine hydrochloride 10 mg tablet | Generic | $0.2415 per tablet |
| chlorpromazine hydrochloride 10 mg tablet, coated | Generic | $0.2415 per tablet |
| chlorpromazine hydrochloride 10 mg tablet, film coated | Generic | $0.2415 per tablet |
| chlorpromazine hydrochloride 10 mg tablet, sugar coated | Generic | $0.2415 per tablet |
| chlorpromazine hydrochloride 100 mg tablet | Generic | $0.4658 per tablet |
| chlorpromazine hydrochloride 100 mg tablet, coated | Generic | $0.4658 per tablet |
| chlorpromazine hydrochloride 100 mg tablet, film coated | Generic | $0.4658 per tablet |
| chlorpromazine hydrochloride 100 mg tablet, sugar coated | Generic | $0.4658 per tablet |
| chlorpromazine hydrochloride 200 mg tablet | Generic | $0.6640 per tablet |
| chlorpromazine hydrochloride 200 mg tablet, coated | Generic | $0.6640 per tablet |
| chlorpromazine hydrochloride 200 mg tablet, film coated | Generic | $0.6640 per tablet |
| chlorpromazine hydrochloride 200 mg tablet, sugar coated | Generic | $0.6640 per tablet |
| chlorpromazine hydrochloride 25 mg tablet | Generic | $0.3287 per tablet |
| chlorpromazine hydrochloride 25 mg tablet, coated | Generic | $0.3287 per tablet |
| chlorpromazine hydrochloride 25 mg tablet, film coated | Generic | $0.3287 per tablet |
| chlorpromazine hydrochloride 25 mg tablet, sugar coated | Generic | $0.3287 per tablet |
| chlorpromazine hydrochloride 50 mg tablet | Generic | $0.3990 per tablet |
| chlorpromazine hydrochloride 50 mg tablet, coated | Generic | $0.3990 per tablet |
| chlorpromazine hydrochloride 50 mg tablet, film coated | Generic | $0.3990 per tablet |
| chlorpromazine hydrochloride 50 mg tablet, sugar coated | Generic | $0.3990 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Remedyrepack Inc.9 products
- American Health Packaging9 products
- Zydus Lifesciences Limited7 products
- Zydus Pharmaceuticals USA Inc.7 products
- Novadoz Pharmaceuticals LLC6 products
- Upsher-Smith Laboratories, LLC5 products
- Alembic Pharmaceuticals Limited5 products
- Alembic Pharmaceuticals Inc.5 products
- Zameer Pharmaceuticals LLC5 products
- AvPAK5 products
- Glenmark Pharmaceuticals Inc., USA5 products
- Golden State Medical Supply, Inc.5 products
- Aurobindo Pharma Limited5 products
- Amneal Pharmaceuticals NY LLC5 products
- Lannett Company, Inc.5 products
- Chartwell RX, LLC5 products
- Saptalis Pharmaceuticals, LLC.2 products
- Advagen Pharma Ltd2 products
- Devatis, Inc.2 products
- Piramal Critical Care Inc2 products
- NorthStar Rx LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Dr. Reddy's Laboratories Inc.2 products
- Eugia US LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Coupler LLC2 products
- Gland Pharma Limited2 products
- Fresenius Kabi USA, LLC2 products
- Sandoz Inc2 products
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Henry Schein, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (25)
- ANDA080365DR Reddys · February 13, 1974
- ANDA083386Upsher Smith Labs · July 9, 1974
- ANDA084112Upsher Smith Labs · July 9, 1974
- ANDA084113Upsher Smith Labs · July 9, 1974
- ANDA084114Upsher Smith Labs · July 9, 1974
- ANDA084115Upsher Smith Labs · July 9, 1974
- ANDA083329Hikma · July 25, 1974
- ANDA080983Sciegen Pharms · March 1, 1976
- ANDA209755Amneal Pharms Co · September 10, 2018
- ANDA213368Zydus Lifesciences · January 17, 2020
- ANDA211816Eugia Pharma · July 7, 2020
- ANDA212996Lannett Co Inc · January 22, 2021
- ANDA212144Glenmark Pharms Ltd · March 23, 2021
- ANDA214542Genus · June 2, 2021
- ANDA212630Chartwell Rx · November 29, 2021
- ANDA214827Msn · January 27, 2022
- ANDA217350Alembic · July 18, 2023
- ANDA217275Zydus Pharms · March 13, 2024
- ANDA218229Regcon Holdings · September 24, 2024
- ANDA216911Gland · October 4, 2024
- ANDA218272Aspiro · November 18, 2024
- ANDA216724Rising · December 10, 2024
- ANDA216788Aurobindo Pharma Ltd · April 25, 2025
- ANDA216678Rubicon Research · October 10, 2025
- ANDA216092Msn · January 26, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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September 3, 2025 · Class II · Ongoing · D-0636-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-113 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0630-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0634-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0632-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0638-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-113 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0633-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0631-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0635-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0637-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01 — Zydus Pharmaceuticals (USA) Inc
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September 3, 2025 · Class II · Ongoing · D-0639-2025
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01 — Zydus Pharmaceuticals (USA) Inc
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August 27, 2025 · Class II · Ongoing · D-0647-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687 — Amerisource Health Services LLC
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August 27, 2025 · Class II · Ongoing · D-0648-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11 — Amerisource Health Services LLC
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August 27, 2025 · Class II · Ongoing · D-0649-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pac — Amerisource Health Services LLC
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August 27, 2025 · Class II · Ongoing · D-0650-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11) — Amerisource Health Services LLC
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August 25, 2025 · Class II · Ongoing · D-0644-2025
Presence of a foreign substance.
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15 — AvKARE
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August 25, 2025 · Class II · Ongoing · D-0643-2025
Presence of a foreign substance.
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15 — AvKARE
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August 18, 2025 · Class II · Ongoing · D-0616-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC — Amneal Pharmaceuticals, LLC
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August 18, 2025 · Class II · Ongoing · D-0617-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, — Amneal Pharmaceuticals, LLC
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August 18, 2025 · Class II · Ongoing · D-0619-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC — Amneal Pharmaceuticals, LLC
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August 18, 2025 · Class II · Ongoing · D-0618-2025
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC — Amneal Pharmaceuticals, LLC
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April 3, 2025 · Class II · Ongoing · D-0361-2025
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-112 — Zydus Pharmaceuticals (USA) Inc
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March 11, 2025 · Class II · Ongoing · D-0309-2025
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01 — Glenmark Pharmaceuticals Inc., USA
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December 11, 2024 · Class II · Ongoing · D-0160-2025
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01 — Glenmark Pharmaceuticals Inc., USA
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December 11, 2024 · Class II · Ongoing · D-0159-2025
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01 — Glenmark Pharmaceuticals Inc., USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Chlorpromazine HciBrand page: products, maker and price
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Chlorpromazine Hydrochloride, Amneal Pharmaceuticals NY LLC, effective May 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →