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Prescription medicine · generic available

Lisinopril and hydrochlorothiazide

Drug class: Thiazide Diuretic

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Lisinopril and hydrochlorothiazide key facts

Drug class
Thiazide Diuretic
Used for
Lisinopril and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. (source)
Prescription or over the counter
Prescription (Rx)
Generic available
Yes
Typical pharmacy cost
$0.0293 per tablet (hydrochlorothiazide 12.5 mg · lisinopril 10 mg; NADAC)
Latest FDA recall
June 20, 2025 (Class II)

Sources: FDA label (July 21, 2026); FDA NDC Directory (October 30, 2026); CMS NADAC (November 4, 2026); FDA enforcement reports (October 27, 2026). Not medical advice.

Quick answers

What is Lisinopril and hydrochlorothiazide used for?
The FDA-approved label (Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, July 21, 2026) says: “Lisinopril and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. …” 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 Lisinopril and hydrochlorothiazide?
The “Adverse Reactions” section of the FDA label (Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, July 21, 2026) begins: “Lisinopril and Hydrochlorothiazide Tablets has been evaluated for safety in 930 patients, including 100 patients treated for 50 weeks or more. In clinical trials with Lisinopril and Hydrochlorothiazide Tablets no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
What are the drug interactions of Lisinopril and hydrochlorothiazide?
The “Drug Interactions” section of the FDA label (Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, July 21, 2026) begins: “Lisinopril Hypotension - Patients on Diuretic Therapy: Patients on diuretics, and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with lisinopril. The possibility of hypotensive effects with lisinopril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Lisinopril and hydrochlorothiazide have a boxed warning?
Yes. The FDA label for Lisinopril and Hydrochlorothiazide has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Lisinopril and hydrochlorothiazide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Lisinopril and hydrochlorothiazide been recalled?
FDA enforcement reports list 5 recalls of products of this medicine; the newest started June 20, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Lisinopril and hydrochlorothiazide?
25 companies list prescription products of Lisinopril and hydrochlorothiazide in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and NuCare Pharmaceuticals, Inc.

What Lisinopril and hydrochlorothiazide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Lisinopril and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. …

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, oral), Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 66 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. Its heading: WARNING: FETAL TOXICITY. Read it on the full label →

66 of 66 FDA labels for this medicine have a boxed warning.

Lisinopril and hydrochlorothiazide boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Lisinopril and Hydrochlorothiazide Tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity.

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. Read the full label on DailyMed →

Lisinopril and hydrochlorothiazide side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Lisinopril and Hydrochlorothiazide Tablets has been evaluated for safety in 930 patients, including 100 patients treated for 50 weeks or more. In clinical trials with Lisinopril and Hydrochlorothiazide Tablets no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.

Read more of this section

The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of lisinopril and hydrochlorothiazide were: dizziness (7.5 percent), headache (5.2 percent), cough (3.9 percent), fatigue (3.7 percent) and orthostatic effects (3.2 percent), all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature; but see WARNINGS regarding angioedema and excessive hypotension or syncope. Discontinuation of therapy due to adverse effects was required in 4.4 percent of patients, principally because of dizziness, cough, fatigue and muscle cramps. Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in controlled clinical trials are shown below. Percent of Patients in Controlled Studies Lisinopril-Hydrochlorothiazide (n=930) Incidence (discontinuation) Placebo (n=207) Incidence Dizziness 7.5 (0.8) 1.9 Headache 5.2 (0.3) 1.9 Cough 3.9 (0.6) 1 Fatigue 3.7 (0.4) 1 Orthostatic Effects 3.2 (0.1) 1 Diarrhea 2.5 (0.2) 2.4 Nausea 2.2 (0.1) 2.4 Upper Respiratory Infection 2.2 (0) 0 Muscle Cramps 2 (0.4) 0.5 Asthenia 1.8 (0.2) 1 Paresthesia 1.5 (0.1) 0 Hypotension 1.4 (0.3) 0.5 Vomiting 1.4 (0.1) 0.5 Dyspepsia 1.3 (0) 0 Rash 1.2 (0.1) 0.5 Impotence 1.2 (0.3) 0 Clinical adverse experiences occurring in 0.3 to 1 percent of patients in controlled trials included: Body as a Whole: Chest pain, abdominal pain, syncope, chest discomfort, fever, trauma, virus infection. Cardiovascular: Palpitation, orthostatic hypotension. Digestive: Gastrointestinal cramps, dry mouth, constipation, heartburn. Musculoskeletal: Back pain, shoulder pain, knee pain, back strain, myalgia, foot pain. Nervous/Psychiatric: Decreased libido, vertigo, depression, somnolence. Respiratory: Common cold, nasal congestion, influenza, bronchitis, pharyngeal pain, dyspnea, pulmonary congestion, chronic sinusitis, allergic rhinitis, pharyngeal discomfort. Skin: Flushing, pruritus, skin inflammation, diaphoresis. Special Senses: Blurred vision, tinnitus, otalgia. Urogenital: Urinary tract infection. Angioedema: Angioedema has been reported in patients receiving Lisinopril and Hydrochlorothiazide Tablets, with an incidence higher in Black than in non-Black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with Lisinopril and Hydrochlorothiazide Tablets should be discontinued and appropriate therapy instituted immediately. In rare cases, intestinal angioedema has been reported with angiotensin converting enzyme inhibitors including lisinopril. (See WARNINGS).

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. This is part of the section. Read the full label on DailyMed →

Lisinopril and hydrochlorothiazide drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Lisinopril Hypotension - Patients on Diuretic Therapy: Patients on diuretics, and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with lisinopril. The possibility of hypotensive effects with lisinopril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril.

Read more of this section

If it is necessary to continue the diuretic, initiate therapy with lisinopril at a dose of 5 mg daily, and provide close medical supervision after the initial dose for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and DOSAGE AND ADMINISTRATION). When a diuretic is added to the therapy of a patient receiving lisinopril, an additional antihypertensive effect is usually observed. (See DOSAGE AND ADMINISTRATION). Non-steroidal Anti-inflammatory Agents Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy. The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs. Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or direct renin inhibitors (such as aliskiren) is associated with increased risk of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end state renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. In general, avoid combined use of RAS inhibitors. Monitor blood pressure, renal function, and electrolytes in patients on Lisinopril and Hydrochlorothiazide Tablets and other agents that affect the RAS. Do not coadminister aliskiren with Lisinopril and Hydrochlorothiazide Tablets in patients with diabetes. Avoid use of aliskiren with Lisinopril and Hydrochlorothiazide Tablets in patients with renal impairment (GFR < 60 mL/min). Other Agents: Lisinopril has been used concomitantly with nitrates and/or digoxin without evidence of clinically significant adverse interactions.

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. This is part of the section. Read the full label on DailyMed →

Lisinopril and hydrochlorothiazide 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.

Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 mg to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 mg to 50 mg per day. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 mg to 80 mg and hydrochlorothiazide doses of 6.25 mg to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component.

Read more of this section

The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. Dose Titration Guided by Clinical Effect A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to Lisinopril and Hydrochlorothiazide Tablets 10 mg/12.5 mg or Lisinopril and Hydrochlorothiazide Tablets 20 mg/12.5 mg. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control with less potassium loss if they are switched to Lisinopril and Hydrochlorothiazide Tablets 10 mg/12.5 mg. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used. Replacement Therapy The combination may be substituted for the titrated individual components. Use in Renal Impairment The usual regimens of therapy with Lisinopril and Hydrochlorothiazide Tablets need not be adjusted as long as the patient’s creatinine clearance is greater than 30 mL/min/1.73 m 2 (serum creatinine approximately less than or equal to 3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Lisinopril and Hydrochlorothiazide Tablets are not recommended (see WARNINGS, Anaphylactoid reactions during membrane exposure).

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. Read the full label on DailyMed →

Lisinopril and hydrochlorothiazide and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

It is not known whether lisinopril is secreted in human milk. However, milk of lactating rats contains radioactivity following administration of 14 C lisinopril. In another study, lisinopril was present in rat milk at levels similar to plasma levels in the dams. Thiazides do appear in human milk.

Read more of this section

Because of the potential for serious reactions in nursing infants from ACE inhibitors and hydrochlorothiazide, a decision should be made whether to discontinue nursing or to discontinue Lisinopril and Hydrochlorothiazide Tablets, taking into account the importance of the drug to the mother.

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. Read the full label on DailyMed →

When Lisinopril and hydrochlorothiazide should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Lisinopril and Hydrochlorothiazide Tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Read more of this section

Lisinopril and Hydrochlorothiazide Tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril and Hydrochlorothiazide Tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS). Do not coadminister aliskiren with Lisinopril and Hydrochlorothiazide Tablets in patients with diabetes.

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. Read the full label on DailyMed →

Lisinopril and hydrochlorothiazide 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).

No specific information is available on the treatment of overdosage with Lisinopril and Hydrochlorothiazide Tablets. Treatment is symptomatic and supportive. Therapy with Lisinopril and Hydrochlorothiazide Tablets should be discontinued and the patient observed closely. Suggested measures include induction of emesis and/or gastric lavage, and correction of dehydration, electrolyte imbalance and hypotension by established procedures.

Read more of this section

Lisinopril Following a single oral dose of 20 g/kg, no lethality occurred in rats and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril can be removed by hemodialysis. (See WARNINGS, Anaphylactoid reactions during membrane exposure). Hydrochlorothiazide Oral administration of a single oral dose of 10 g/kg to mice and rats was not lethal. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

— FDA label: Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026. Read the full label on DailyMed →

Forms and how it is given

Dosage formsTablet
RouteOral
Prescription products95 in the FDA NDC Directory
Brand namesZestoretic

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.

NADAC per unit for Lisinopril and hydrochlorothiazide, by strength and form
Strength and formGeneric or brandPharmacies pay
hydrochlorothiazide 12.5 mg · lisinopril 10 mg
tablet
Generic $0.0293 per tablet
hydrochlorothiazide 12.5 mg · lisinopril 20 mg
tablet
Generic $0.0358 per tablet
hydrochlorothiazide 25 mg · lisinopril 20 mg
tablet
Generic $0.0405 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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA019888
ZESTORETIC
AlmaticaJuly 20, 1989 53, latest August 20, 2020
2020: Labeling · 2017: Labeling · 2015: Labeling

Generic approvals (6)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. June 20, 2025 · Class II · Ongoing · D-0532-2025

    Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

    Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01 — Lupin Pharmaceuticals Inc.

  2. January 26, 2022 · Class II · Terminated · D-0188-2024

    CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, Ind — CARDINAL HEALTHCARE

  3. July 19, 2019 · Class II · Terminated · D-1581-2019

    Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.

    Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, — Lupin Pharmaceuticals Inc.

  4. July 17, 2019 · Class II · Terminated · D-1720-2019

    Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

    Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-0 — Lupin Pharmaceuticals Inc.

  5. April 4, 2016 · Class III · Terminated · D-1052-2016

    CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

    Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupi — Lupin Pharmaceuticals Inc.

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

RxCUI (RxNorm)197885, 197886, 197887
SPL set ID of the quoted labeld7214539-6c3d-466a-a474-6fde096fa182
FDA labels (SPL)66
FDA applicationsNDA019888, 6 ANDA
Active ingredients (FDA)HYDROCHLOROTHIAZIDE / LISINOPRIL

Next steps

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Lisinopril and Hydrochlorothiazide, Aurobindo Pharma Limited, effective July 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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