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Aurobindo Pharma USA Recalls
59 recalls on record · June 5, 2013 to August 12, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026DrugsFDA
Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 P
Hazard: shortfill; reports of empty capsules.
June 25, 2025DrugsFDA
Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,
Hazard: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
December 25, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
December 11, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-
Hazard: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
December 11, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8
Hazard: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
December 11, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-
Hazard: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
August 28, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distrib
Hazard: Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
May 15, 2024DrugsFDA
Aurobindo Pharma USA Inc. recalls Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, ND
Hazard: Discoloration: Dotted and yellow spots on tablets
May 15, 2024DrugsFDA
Aurobindo Pharma USA Inc. recalls Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, ND
Hazard: Discoloration: Dotted and yellow spots on tablets
September 27, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-127
Hazard: Failed dissolution specifications - results obtained were below spec average.
August 30, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Hazard: cGMP deviations: Batch was released prior to approval.
August 30, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Hazard: cGMP deviations: Batch was released prior to approval.
May 31, 2023DrugsFDA
Aurobindo Pharma USA Inc. recalls Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walg
Hazard: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
November 2, 2022DrugsFDA
Aurobindo Pharma USA Inc. recalls Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc
Hazard: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
April 20, 2022DrugsFDA
Aurobindo Pharma USA Inc. recalls Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for A
Hazard: Subpotent Drug: Out of Specification results for Assay
February 23, 2022DrugsFDA
Aurobindo Pharma USA Inc. recalls Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
Hazard: Failed Impurities/Degradation Specifications
February 2, 2022DrugsFDA
Aurobindo Pharma USA Inc. recalls Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC
Hazard: Superpotent and Failed Tablet/Capsule Specifications
December 1, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-
Hazard: Failed Impurities/Degradation Specifications
September 29, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princ
Hazard: Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
August 18, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Auro
Hazard: Presence of Foreign Substance- Potential of metal contamination.
March 10, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-High
Hazard: Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
November 11, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 m
Hazard: Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
September 2, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distribu
Hazard: Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
July 1, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton
Hazard: Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
June 24, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Man
Hazard: Failed Impurities/ Degradation Specifications
June 24, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Man
Hazard: Failed Impurities/ Degradation Specifications
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA,
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, N
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, ND
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed