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Browse Drug Recalls

49 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 49 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 49 FDA drug recalls.

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DateProductReasonClassFirm
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 Aurobindo Pharma USA Inc.
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 Aurobindo Pharma USA Inc.
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 Aurobindo Pharma USA Inc.
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 Aurobindo Pharma USA Inc.
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 Aurobindo Pharma USA Inc.
May 22, 2023 Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged ... Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for... Class II Aurobindo Pharma USA Inc.
Oct 5, 2022 Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottle... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Aurobindo Pharma USA Inc.
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 Aurobindo Pharma USA Inc.
Jan 14, 2022 Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only... Failed Impurities/Degradation Specifications Class II Aurobindo Pharma USA Inc.
Dec 29, 2021 Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo... Superpotent and Failed Tablet/Capsule Specifications Class II Aurobindo Pharma USA Inc.
Nov 15, 2021 Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by... Failed Impurities/Degradation Specifications Class III Aurobindo Pharma USA Inc.
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 of metal wire in one ... Class II Aurobindo Pharma USA Inc.
Jul 7, 2021 Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, ... Presence of Foreign Substance- Potential of metal contamination. Class II Aurobindo Pharma USA Inc.
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 tablets were found in a... Class II Aurobindo Pharma USA Inc.
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 dosing cups. Class III Aurobindo Pharma USA Inc.
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 for the presence of m... Class II Aurobindo Pharma USA Inc.
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 being present in 500 cou... Class II Aurobindo Pharma USA Inc.
May 26, 2020 Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III Aurobindo Pharma USA Inc.
May 26, 2020 Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
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 water leakage was observed Class II Aurobindo Pharma USA Inc.
Nov 6, 2019 Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Sep 19, 2019 Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate... Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for wei... Class II Aurobindo Pharma USA Inc.
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 lot number 05318054... Class III Aurobindo Pharma USA Inc.
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 Aurobindo Pharma USA Inc.
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-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
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-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
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 impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
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 impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
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-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
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-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
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 impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
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 impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
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 impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
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-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
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-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
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 report that tablets f... Class III Aurobindo Pharma USA Inc.
Apr 9, 2013 Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufa... Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label Class III Aurobindo Pharma USA Inc

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.