Aurobindo Pharma USA Inc.

Complete recall history across all FDA and CPSC categories — 47 total recalls

Aurobindo Pharma USA Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (47)

FDA drug safety enforcement actions by Aurobindo Pharma USA Inc.

Date Product Reason Class
Apr 24, 2024 Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC... Discoloration: Dotted and yellow spots on tablets Class II
Apr 24, 2024 Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC ... Discoloration: Dotted and yellow spots on tablets Class II
Aug 2, 2023 Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc... Failed dissolution specifications - results obtained were below spec average. Class II
Jul 21, 2023 Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II
Jul 21, 2023 Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II
May 22, 2023 Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged ... Failed Impurities/Degradation Specifications: firm's investigation due to cus... Class II
Oct 5, 2022 Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottle... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptab... Class II
Apr 5, 2022 Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... Subpotent Drug: Out of Specification results for Assay Class III
Jan 14, 2022 Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only... Failed Impurities/Degradation Specifications Class II
Dec 29, 2021 Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo... Superpotent and Failed Tablet/Capsule Specifications Class II
Nov 15, 2021 Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by... Failed Impurities/Degradation Specifications Class III
Sep 9, 2021 Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distribu... Presence of Foreign Substance: Product complaints received for the presence o... Class II
Jul 7, 2021 Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, ... Presence of Foreign Substance- Potential of metal contamination. Class II
Jan 20, 2021 Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Au... Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tab... Class II
Oct 22, 2020 Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL ... Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosi... Class III
Aug 10, 2020 Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength... Presence of Foreign Substance: product complaints were received by the firm f... Class II
Jun 12, 2020 Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed b... Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg bein... Class II
May 26, 2020 Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III
May 26, 2020 Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Auro... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aur... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx ... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed ... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Mar 18, 2020 Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: ... CGMP Deviations: Products were manufactured in a processing area in which wat... Class II
Sep 19, 2019 Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate... Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of s... Class II
Jul 29, 2019 Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: A... Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with... Class III
Mar 28, 2019 Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, M... Presence of Particulate Matter: One vial was found to contain a hair. Class I
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurob... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 31, 2018 Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aur... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Auro... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactur... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 31, 2018 Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Auro... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impur... Class II
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Dec 31, 2018 Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Au... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylami... Class II
Nov 30, 2018 Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bo... Discoloration: This product is being recalled due to a confirmed pharmacist r... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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