Quick answers
- What is Moxifloxacin used for?
- The FDA-approved label (Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., September 4, 2026) says: “Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia Skin and Skin Structure Infections …” 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 Moxifloxacin?
- The “Adverse Reactions” section of the FDA label (Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., September 4, 2026) begins: “The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: • Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions (5.1)] • Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)] • Peripheral Neuropathy [see Warnings and Precautions …” … 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 Moxifloxacin?
- The “Drug Interactions” section of the FDA label (Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., September 4, 2026) begins: “Interacting Drug Interaction Multivalent cation-containing products including: antacids, sucralfate, multivitamins Decreased Moxifloxacin hydrochloride absorption. Take moxifloxacin tablet at least 4 hours before or 8 hours after these products. (2.2, 7.1, 12.3) Warfarin Anticoagulant effect enhanced. Monitor prothrombin time/INR, and bleeding. (6, 7.2, 12.3) Class IA and Class III antiarrhythmics: Proarrhythmic effect may be enhanced. Avoid concomitant use.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Moxifloxacin have a boxed warning?
- Yes. The FDA label for Moxifloxacin Hydrochloride Tablets, 400 mg has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Moxifloxacin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Moxifloxacin been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started January 14, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Moxifloxacin?
- 36 companies list prescription products of Moxifloxacin in the FDA NDC Directory, including A-S Medication Solutions, PD-Rx Pharmaceuticals, Inc. and Redpharm Drug.
What Moxifloxacin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia Skin and Skin Structure Infections …
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 52 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 →
25 of 52 FDA labels for this medicine have a boxed warning.
Moxifloxacin boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [See warnings and Precautions (5.1)], including: Tendinitis and tendon rupture [See warnings and Precautions (5.2)] Peripheral Neuropathy …
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. This is part of the section. Read the full label on DailyMed →
Moxifloxacin side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label:
- Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions (5.1)]
- Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)]
- Peripheral Neuropathy [see Warnings and Precautions …
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. This is part of the section. Read the full label on DailyMed →
Moxifloxacin 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.
Interacting Drug Interaction Multivalent cation-containing products including: antacids, sucralfate, multivitamins Decreased Moxifloxacin hydrochloride absorption. Take moxifloxacin tablet at least 4 hours before or 8 hours after these products. (2.2, 7.1, 12.3) Warfarin Anticoagulant effect enhanced. Monitor prothrombin time/INR, and bleeding. (6, 7.2, 12.3) Class IA and Class III antiarrhythmics: Proarrhythmic effect may be enhanced. Avoid concomitant use.
Read more of this section
(5.6, 7.5) Antidiabetic agents Carefully monitor blood glucose. (5.11, 7.3) 7.1 Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations Fluoroquinolones, including moxifloxacin hydrochloride, form chelates with alkaline earth and transition metal cations. Oral administration of moxifloxacin hydrochloride with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of moxifloxacin hydrochloride, resulting in systemic concentrations considerably lower than desired. Therefore, moxifloxacin hydrochloride should be taken at least 4 hours before or 8 hours after these agents. [See Dosage and Administration (2.2), and Clinical Pharmacology (12.3).] 7.2 Warfarin Fluoroquinolones, including moxifloxacin hydrochloride, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. In addition, infectious disease and its accompanying inflammatory process, age, and general status of the patient are risk factors for increased anticoagulant activity. Therefore the prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if moxifloxacin hydrochloride is administered concomitantly with warfarin or its derivatives. [See Adverse Reactions (6.2), Clinical Pharmacology (12.3).] 7.3 Antidiabetic Agents Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones including moxifloxacin hydrochloride and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered. If a hypoglycemic reaction occurs, moxifloxacin hydrochloride should be discontinued and appropriate therapy should be initiated immediately. [See Warnings and Precautions (5.11) and Adverse Reactions (6.1)]. 7.4 Nonsteroidal Anti-Inflammatory Drugs The concomitant administration of a nonsteroidal anti-inflammatory drug (NSAID) with a fluoroquinolones, including moxifloxacin hydrochloride, may increase the risks of CNS stimulation and convulsions [see Warnings and Precautions (5.4)]. 7.5 Drugs that Prolong QT There is limited information available on the potential for a pharmacodynamic interaction in humans between moxifloxacin hydrochloride and other drugs that prolong the QTc interval of the electrocardiogram.
Table from the label
| Interacting Drug | Interaction |
|---|---|
| Multivalent cation-containing products including : antacids, sucralfate, multivitamins | Decreased Moxifloxacin hydrochloride absorption. Take moxifloxacin tablet at least 4 hours before or 8 hours after these products. ( 2.2, 7.1, 12.3) |
| Warfarin | Anticoagulant effect enhanced. Monitor prothrombin time/INR, and bleeding. (6, 7.2, 12.3) |
| Class IA and Class III antiarrhythmics: | Proarrhythmic effect may be enhanced. Avoid concomitant use. ( 5.6, 7.5) |
| Antidiabetic agents | Carefully monitor blood glucose. ( 5.11, 7.3) |
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. This is part of the section. Read the full label on DailyMed →
Moxifloxacin 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.
� Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia (1.1) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) (1.2) 400 mg 7 Complicated SSSI (1.3) 400 mg 7 to 21 Complicated Intra-Abdominal Infections (1.4) 400 mg 5 to 14 Plague (1.5) 400 mg 10 to 14 Acute Bacterial Sinusitis (1.6) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis (1.7) 400 mg 5 No dosage adjustment in patients with renal or hepatic impairment.
Read more of this section
(8.6, 8.7) 2.1 Dosage in Adult Patients The dose of moxifloxacin tablets is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1. Table 1: Dosage and Duration of Therapy in Adult Patients Type of Infection a Dose Every 24 hours Duration b (days) Community Acquired Pneumonia (1.1) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) (1.2) 400 mg 7 Complicated SSSI (1.3) 400 mg 7 to 21 Complicated Intra-Abdominal Infections (1.4) 400 mg 5 to 14 Plague (1.5) c 400 mg 10 to 14 Acute Bacterial Sinusitis (ABS) (1.6) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) (1.7) 400 mg 5 a) Due to the designated pathogens [see Indications and Usage (1)]. b) Sequential therapy (oral) may be instituted at the discretion of the physician. c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Conversion of Intravenous to Oral Dosing in Adults Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with moxifloxacin hydrochloride injection may be switched to Moxifloxacin tablets when clinically indicated at the discretion of the physician. 2.2 Important Administration Instructions Moxifloxacin Tablets With Multivalent Cations Administer moxifloxacin tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. With Food Moxifloxacin Tablets can be taken with or without food, drink fluids liberally.
Table from the label
| Type of Infection | Dose Every 24 hours | Duration (days) |
|---|---|---|
| Community Acquired Pneumonia ( 1.1) | 400 mg | 7 to 14 |
| Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2) | 400 mg | 7 |
| Complicated SSSI ( 1.3) | 400 mg | 7 to 21 |
| Complicated Intra-Abdominal Infections ( 1.4) | 400 mg | 5 to 14 |
| Plague ( 1.5) | 400 mg | 10 to 14 |
| Acute Bacterial Sinusitis ( 1.6) | 400 mg | 10 |
| Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7) | 400 mg | 5 |
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. This is part of the section. Read the full label on DailyMed →
Moxifloxacin in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, moxifloxacin may cause fetal harm. Moxifloxacin was not teratogenic when administered to pregnant rats (IV and oral), rabbits (IV), and monkeys (oral) at exposures that were 0.25–2.5 times of those at the human clinical dose (400 mg/day moxifloxacin).
Read more of this section
However, when moxifloxacin was administered to rats and rabbits during pregnancy and throughout lactation (rats only) at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed (see Data). Advise pregnant women of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Animal Data Animal reproductive and development studies were done in rats, rabbits and cynomolgus macaques. Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis (gestation days 6 to 17) at oral doses as high as 500 mg/kg/day or 0.24 times the maximum recommended human dose based on systemic exposure (AUC), but decreased fetal body weights and slightly delayed fetal skeletal development were observed. Intravenous administration of 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) to pregnant rats resulted in maternal toxicity and a marginal effect on fetal and placental weights and the appearance of the placenta (Gestation days 6 to 17). There was no evidence of teratogenicity at intravenous doses as high as 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) in pregnant rats during organogenesis (Gestation days 6 to 17). Intravenous administration of 20 mg/kg/day (approximately equal to the maximum recommended human oral dose based upon systemic exposure) to pregnant rabbits during organogenesis (gestation days 6 to 20) resulted in decreased fetal body weights and delayed fetal skeletal ossification. When rib and vertebral malformations were combined, there was an increased fetal and litter incidence of these effects in rabbits. Signs of maternal toxicity in rabbits at this dose included mortality, abortions, marked reduction of food consumption, decreased water intake, body weight loss and hypoactivity. There was no evidence of teratogenicity when pregnant cynomolgus macaques were given oral doses as high as 100 mg/kg/day (2.5 times the maximum recommended human dose based upon systemic exposure) during organogenesis (gestation days 20 to 50). An increased incidence of smaller fetuses was observed at 100 mg/kg/day in macaques.
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. This is part of the section. Read the full label on DailyMed →
When Moxifloxacin should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Moxifloxacin hydrochloride is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8)]. Known hypersensitivity to Moxifloxacin hydrochloride or other quinolones (4, 5.8)
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. Read the full label on DailyMed →
Moxifloxacin 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).
Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, Empty the stomach and maintain adequate hydration. Monitor ECG due to the possibility of QT interval prolongation. Carefully observe the patient and give supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure.
Read more of this section
About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.
— FDA label: Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution/ drops · Tablet, film coated · Injection, solution · Solution |
|---|---|
| Route | Ophthalmic · Oral · Intravenous |
| Prescription products | 58 in the FDA NDC Directory |
| Brand names | Vigamox |
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 |
|---|---|---|
| moxifloxacin hydrochloride 400 mg tablet, film coated | Generic | $1.42 per tablet |
| moxifloxacin hydrochloride 5 mg/mL solution | Generic | $1.66 per mL |
| moxifloxacin hydrochloride 5 mg/mL solution/ drops | Generic | $1.66 per mL |
| moxifloxacin hydrochloride 5 mg/mL solution/ drops | Brand: Vigamox | $31.81 per mL |
| moxifloxacin hydrochloride monohydrate 400 mg tablet, film coated | Generic | $1.42 per tablet |
| moxifloxacin hydrochloride monohydrate 5 mg/mL solution/ drops | Generic | $1.66 per mL |
NADAC list of November 4, 2026; these prices took effect between June 17, 2026 and 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.
- A-S Medication Solutions7 products
- PD-Rx Pharmaceuticals, Inc.5 products
- Redpharm Drug4 products
- Bryant Ranch Prepack4 products
- Remedyrepack Inc.3 products
- Aurobindo Pharma Limited2 products
- Lupin Pharmaceuticals, Inc.2 products
- Direct_Rx2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Sandoz Inc1 product
- Dr. Reddy's Laboratories Limited1 product
- Fresenius Kabi USA, LLC1 product
- Macleods Pharmaceuticals Limited1 product
- Asclemed USA, Inc.1 product
- Alembic Pharmaceuticals Inc.1 product
- Gland Pharma Limited1 product
- Major Pharmaceuticals1 product
- Camber Pharmaceuticals, Inc.1 product
- AvPAK1 product
- Upsher-Smith Laboratories, LLC1 product
- Chartwell RX, LLC1 product
- Mylan Institutional LLC1 product
- Lifestar Pharma LLC1 product
- Fosun Pharma USA Inc.1 product
- Proficient Rx LP1 product
- American Health Packaging1 product
- NorthStar Rx LLC1 product
- Rising Pharma Holdings, Inc.1 product
- Harrow Eye, LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Hp Halden Pharma AS1 product
- Somerset Therapeutics, LLC1 product
- Solaris Pharma Corporation1 product
- Novadoz Pharmaceuticals LLC1 product
- Golden State Medical Supply, Inc.1 product
- Apotex Corp.1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021598 VIGAMOX | Harrow Eye | April 15, 2003 | 8, latest June 2, 2020 2020: Labeling · 2020: Labeling · 2017: Labeling |
| NDA205572 MOXIFLOXACIN HYDROCHLORIDE | Fresenius Kabi USA | April 3, 2015 | 6, latest March 27, 2020 2020: Labeling · 2019: Labeling · 2019: Manufacturing (CMC) |
Generic approvals (18)
- ANDA076938DR Reddys · March 4, 2014
- ANDA202632Aurobindo Pharma Ltd · March 4, 2014
- ANDA202867Lupin · September 4, 2014
- ANDA204079Lupin · May 28, 2015
- ANDA207285Chartwell Rx · February 13, 2017
- ANDA205833Mylan Labs Ltd · May 5, 2017
- ANDA090080Apotex · June 30, 2017
- ANDA208682Msn · September 22, 2017
- ANDA206242Eugia Pharma · October 4, 2017
- ANDA202916Epic Pharma LLC · November 9, 2017
- ANDA206295Sunshine · September 28, 2018
- ANDA209469Alembic · February 13, 2019
- ANDA208778Gland · March 30, 2020
- ANDA212616Upsher Smith Labs · February 10, 2021
- ANDA204836Hetero Labs Ltd V · March 2, 2023
- ANDA209698Somerset Theraps LLC · November 14, 2024
- ANDA217988Mankind Pharma · January 27, 2025
- ANDA209143Macleods Pharms · March 2, 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.
-
January 14, 2022 · Class II · Terminated · D-0560-2022
Failed Impurities/Degradation Specifications
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03 — Aurobindo Pharma USA Inc.
-
December 2, 2019 · Class III · Terminated · D-0789-2020
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03. — AuroMedics Pharma LLC
-
February 26, 2019 · Class III · Terminated · D-0517-2019
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01. — Lupin Pharmaceuticals Inc.
-
February 1, 2019 · Class III · Terminated · D-0484-2019
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-4 — Lupin Pharmaceuticals Inc.
-
July 26, 2018 · Class III · Terminated · D-1050-2018
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC — 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) | 311787, 351156, 403818, 404473 |
|---|---|
| SPL set ID of the quoted label | bdb3f89a-01e7-411d-b071-48e87def0873 |
| FDA labels (SPL) | 52 |
| FDA applications | NDA021598, NDA205572, 18 ANDA |
| Active ingredients (FDA) | MOXIFLOXACIN |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- VigamoxBrand page: products, maker and price
- PneumoniaCondition named on the label: hospitals that treat it
- A-S Medication SolutionsMaker or distributor
- PD-Rx Pharmaceuticals, Inc.Maker or distributor
- Redpharm DrugMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Moxifloxacin Hydrochloride Tablets, 400 mg, Remedyrepack Inc., effective September 4, 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 →