Aurobindo Pharma Usa recalls
Aurobindo Pharma Usa appears in 59 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 59 |
|---|---|
| Published | 2013-06-05 to 2026-08-12 |
| By agency | FDA Drug (59) |
| By classification | Class II (48), Class III (9), Class I (2) |
| By status | terminated (33), ongoing (24), completed (2) |
| Distribution named in notices | CA, GA, NC, NJ, NM, NY, PA, TX, US |
Recalls
- Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown…
FDA Drug · Class II · 2026-08-12 · Aurobindo Pharma Usa
Reason: shortfill; reports of empty capsules. - Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 7228…
FDA Drug · Class II · 2025-06-25 · Aurobindo Pharma Usa
Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). - Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Wind…
FDA Drug · Class II · 2024-12-25 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. - 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, D…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit - 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, Di…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit - Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30)
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit - Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth…
FDA Drug · Class I · 2024-08-28 · Aurobindo Pharma Usa
Reason: Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. - 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…
FDA Drug · Class II · 2024-05-15 · Aurobindo Pharma Usa
Reason: Discoloration: Dotted and yellow spots on tablets - 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…
FDA Drug · Class II · 2024-05-15 · Aurobindo Pharma Usa
Reason: Discoloration: Dotted and yellow spots on tablets - Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc
FDA Drug · Class II · 2023-09-27 · Aurobindo Pharma Usa
Reason: Failed dissolution specifications - results obtained were below spec average. - Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown…
FDA Drug · Class II · 2023-08-30 · Aurobindo Pharma Usa
Reason: cGMP deviations: Batch was released prior to approval. - Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown…
FDA Drug · Class II · 2023-08-30 · Aurobindo Pharma Usa
Reason: cGMP deviations: Batch was released prior to approval. - Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmo…
FDA Drug · Class II · 2023-05-31 · Aurobindo Pharma Usa
Reason: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity. - Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hig…
FDA Drug · Class II · 2022-11-02 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. - 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 LL…
FDA Drug · Class III · 2022-04-20 · Aurobindo Pharma Usa
Reason: Subpotent Drug: Out of Specification results for Assay - Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ…
FDA Drug · Class II · 2022-02-23 · Aurobindo Pharma Usa
Reason: Failed Impurities/Degradation Specifications - Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
FDA Drug · Class II · 2022-02-02 · Aurobindo Pharma Usa
Reason: Superpotent and Failed Tablet/Capsule Specifications - Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, Ea…
FDA Drug · Class III · 2021-12-01 · Aurobindo Pharma Usa
Reason: Failed Impurities/Degradation Specifications - Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road…
FDA Drug · Class II · 2021-09-29 · Aurobindo Pharma Usa
Reason: Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet. - Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, In…
FDA Drug · Class II · 2021-08-18 · Aurobindo Pharma Usa
Reason: Presence of Foreign Substance- Potential of metal contamination. - Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Wi…
FDA Drug · Class II · 2021-03-10 · Aurobindo Pharma Usa
Reason: Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg. - 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, D…
FDA Drug · Class III · 2020-11-11 · Aurobindo Pharma Usa
Reason: Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. - Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo P…
FDA Drug · Class II · 2020-09-02 · Aurobindo Pharma Usa
Reason: Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s). - Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road Ea…
FDA Drug · Class II · 2020-07-01 · Aurobindo Pharma Usa
Reason: Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. - Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurol…
FDA Drug · Class III · 2020-06-24 · Aurobindo Pharma Usa
Reason: Failed Impurities/ Degradation Specifications - Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurol…
FDA Drug · Class III · 2020-06-24 · Aurobindo Pharma Usa
Reason: Failed Impurities/ Degradation Specifications - Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Day…
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Day…
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Day…
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East…
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
FDA Drug · Class II · 2020-04-22 · Aurobindo Pharma Usa
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Enti…
FDA Drug · Class II · 2019-10-23 · Aurobindo Pharma Usa
Reason: Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. - Simvastatin Tablets, USP 40 mg
FDA Drug · Class III · 2019-09-04 · Aurobindo Pharma Usa
Reason: Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B - Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 ND…
FDA Drug · Class I · 2019-04-17 · Aurobindo Pharma Usa
Reason: Presence of Particulate Matter: One vial was found to contain a hair. - Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
FDA Drug · Class II · 2019-03-27 · Aurobindo Pharma Usa
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
FDA Drug · Class II · 2019-03-27 · Aurobindo Pharma Usa
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
FDA Drug · Class II · 2019-03-27 · Aurobindo Pharma Usa
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
FDA Drug · Class II · 2019-03-27 · Aurobindo Pharma Usa
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by…
FDA Drug · Class II · 2019-03-27 · Aurobindo Pharma Usa
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810
FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton…
FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810
FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton…
FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton…
FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810
FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. - Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810
FDA Drug · Class II · 2019-01-23 · Aurobindo Pharma Usa
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.