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Browse Drug Recalls

36 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 36 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 36 FDA drug recalls.

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DateProductReasonClassFirm
Mar 7, 2025 Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 6... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Direct Rx
Mar 7, 2025 Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distribu... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Direct Rx
Jan 31, 2025 CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, ... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II Direct Rx
Aug 9, 2024 Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 80... Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-mo... Class II Direct Rx
Mar 22, 2023 Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distribute... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 22, 2023 Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed ... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 22, 2023 Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 13, 2023 Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... cGMP deviations Class II Direct Rx
Mar 13, 2023 Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-c... cGMP deviations Class II Direct Rx
Mar 13, 2023 Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... cGMP deviations Class II Direct Rx
Mar 13, 2023 Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... cGMP deviations Class II Direct Rx
Mar 13, 2023 Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72... cGMP deviations Class II Direct Rx
Mar 13, 2023 Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II Direct Rx
Mar 13, 2023 Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II Direct Rx
Mar 13, 2023 Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC... cGMP deviations Class II Direct Rx
Mar 13, 2023 Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-04... cGMP deviations Class II Direct Rx
Mar 13, 2023 Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... cGMP deviations Class II Direct Rx
Mar 13, 2023 Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... cGMP deviations Class II Direct Rx
Nov 2, 2022 Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... cGMP deviation: discontinue of stability support for product. Class II Direct Rx
Sep 12, 2022 Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distrib... CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... Class II Direct Rx
May 13, 2022 Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Dist... CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Class II Direct Rx
May 11, 2022 Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II Direct Rx
May 11, 2022 Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distribute... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II Direct Rx
May 11, 2022 Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distribut... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class II Direct Rx
May 5, 2022 Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonv... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Direct Rx
Mar 4, 2022 Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Mar 4, 2022 Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Feb 17, 2022 Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By:... Failed impurities/degradation specifications Class II Direct Rx
Dec 7, 2021 Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distri... Defective Container: Leaking containers. Class II Direct Rx
Sep 14, 2021 Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Di... CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Class II Direct Rx
Mar 2, 2021 Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Pac... cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently tak... Class II Direct Rx
Oct 12, 2020 Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Daw... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Direct Rx
Jan 15, 2020 Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-3... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Direct Rx
Jan 15, 2020 Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Dir... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Direct Rx
Apr 30, 2019 Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distribute... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Direct Rx
Mar 12, 2019 Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx D... CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in th... Class II Direct Rx

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.