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Aurobindo Pharma USA Inc.: 58 FDA recall reports

Every drug recall the FDA has published for Aurobindo Pharma USA Inc.. The fault, and how the agency graded it.

58Reports

2Class I

23Ongoing

2025-06-25Most recent

2 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	47
Class III	9
Class I	2

By year reported

Year	Reports
2013	1
2015	1
2016	1
2017	2
2018	1
2019	18
2020	14
2021	4
2022	4
2023	4
2024	7
2025	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N.

D-0471-2025 · Class II · reported 2025-06-25 · Ongoing

Why it was recalled: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Product: Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Where it went: USA Nationwide.
How much: 4,608 bottles

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princet

D-0149-2025 · Class II · reported 2024-12-25 · Ongoing

Why it was recalled: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Product: Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
Where it went: Nationwide in the USA

Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (N

D-0078-2025 · Class II · reported 2024-12-11 · Ongoing

Why it was recalled: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product: Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Where it went: USA Nationwide
How much: 3336 bottles

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (

D-0077-2025 · Class II · reported 2024-12-11 · Ongoing

Why it was recalled: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product: Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Where it went: USA Nationwide
How much: 102576 bottles

Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (

D-0079-2025 · Class II · reported 2024-12-11 · Ongoing

Why it was recalled: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product: Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
Where it went: USA Nationwide

Class I

Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottle

D-0641-2024 · Class I · reported 2024-08-28 · Ongoing

Why it was recalled: Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Product: Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.
Where it went: NJ, NY & PA
How much: 240 bottles

Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per

D-0492-2024 · Class II · reported 2024-05-15 · Ongoing

Why it was recalled: Discoloration: Dotted and yellow spots on tablets
Product: Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Where it went: Nationwide in the USA
How much: 6909 bottles

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per

D-0491-2024 · Class II · reported 2024-05-15 · Ongoing

Why it was recalled: Discoloration: Dotted and yellow spots on tablets
Product: Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Where it went: Nationwide in the USA
How much: 6696 bottles

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., ND

D-1171-2023 · Class II · reported 2023-09-27 · Terminated

Why it was recalled: Failed dissolution specifications - results obtained were below spec average.
Product: Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Where it went: USA nationwide
How much: 9,890 bottles

Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA,

D-1088-2023 · Class II · reported 2023-08-30 · Terminated

Why it was recalled: cGMP deviations: Batch was released prior to approval.
Product: Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
Where it went: USA nationwide
How much: 48 bottles

Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA,

D-1087-2023 · Class II · reported 2023-08-30 · Terminated

Why it was recalled: cGMP deviations: Batch was released prior to approval.
Product: Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08
Where it went: USA nationwide
How much: 48 bottles

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distribute

D-0765-2023 · Class II · reported 2023-05-31 · Completed

Why it was recalled: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Product: Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.
Where it went: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
How much: 87,360 bottles

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharm

D-0021-2023 · Class II · reported 2022-11-02 · Completed

Why it was recalled: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Product: Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
Where it went: Nationwide
How much: 9504 bottles

Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in In

D-0766-2022 · Class III · reported 2022-04-20 · Terminated

Why it was recalled: Subpotent Drug: Out of Specification results for Assay
Product: Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Where it went: Nationwide in the USA.
How much: 433,809 vials

Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharm

D-0560-2022 · Class II · reported 2022-02-23 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications
Product: 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
Where it went: USA Nationwide
How much: 115776 bottles

Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor,

D-0450-2022 · Class II · reported 2022-02-02 · Terminated

Why it was recalled: Superpotent and Failed Tablet/Capsule Specifications
Product: Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Where it went: Nationwide in the US
How much: 792 bottles

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279

D-0263-2022 · Class III · reported 2021-12-01 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications
Product: Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Where it went: Nationwide in the US
How much: 7296 containers

Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc.

D-0812-2021 · Class II · reported 2021-09-29 · Terminated

Why it was recalled: Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Product: Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
Where it went: Nationwide within the United States
How much: 2,820 bottles

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distribute

D-0719-2021 · Class II · reported 2021-08-18 · Terminated

Why it was recalled: Presence of Foreign Substance- Potential of metal contamination.
Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Where it went: Nationwide
How much: 3800 bottles

Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Prin

D-0290-2021 · Class II · reported 2021-03-10 · Terminated

Why it was recalled: Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Product: Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99
Where it went: TX, CA, GA, PA
How much: 1296 bottles

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl

D-0065-2021 · Class III · reported 2020-11-11 · Terminated

Why it was recalled: Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Product: Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92
Where it went: NJ
How much: 7440 bottles

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only

D-1535-2020 · Class II · reported 2020-09-02 · Terminated

Why it was recalled: Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Product: Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.
Where it went: Nationwide in the U.S.
How much: 5748 bottles

Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279

D-1370-2020 · Class II · reported 2020-07-01 · Terminated

Why it was recalled: Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Product: Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Where it went: U.S.A. Nationwide
How much: 1440 bottles

Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 4504

D-1315-2020 · Class III · reported 2020-06-24 · Terminated

Why it was recalled: Failed Impurities/ Degradation Specifications
Product: Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
Where it went: U.S.A. Nationwide
How much: 7547 bottles

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 4504

D-1314-2020 · Class III · reported 2020-06-24 · Terminated

Why it was recalled: Failed Impurities/ Degradation Specifications
Product: Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
Where it went: U.S.A. Nationwide
How much: 13322 bottles

Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton

D-1232-2020 · Class II · reported 2020-04-22 · Terminated

Why it was recalled: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product: Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Where it went: Nationwide within the United States
How much: 26625 units

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Au

D-1231-2020 · Class II · reported 2020-04-22 · Terminated

Why it was recalled: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product: Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
Where it went: Nationwide within the United States
How much: 57337 units

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Au

D-1229-2020 · Class II · reported 2020-04-22 · Terminated

Why it was recalled: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product: Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Where it went: Nationwide within the United States
How much: 14194 units

Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Day

D-1236-2020 · Class II · reported 2020-04-22 · Terminated

Why it was recalled: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product: Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
Where it went: Nationwide within the United States
How much: 2101 units

Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279

D-1233-2020 · Class II · reported 2020-04-22 · Terminated

Why it was recalled: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product: Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
Where it went: Nationwide within the United States
How much: 8040 units

Showing the 30 most recent of 58. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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