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Browse Drug Recalls

65 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 65 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 65 FDA drug recalls.

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DateProductReasonClassFirm
Jun 26, 2018 Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Jun 26, 2018 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Jun 19, 2018 Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDP... Failed Impurities/Degradation Specifications Class III Wockhardt Limited
Jun 19, 2018 Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE ... Failed Impurities/Degradation Specifications Class III Wockhardt Limited
Aug 22, 2017 Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufacture... Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specificatio... Class III Wockhardt Usa Inc.
Jul 29, 2015 Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: ... CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class II Wockhardt Usa Inc.
Jul 29, 2015 Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: W... CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class II Wockhardt Usa Inc.
Jun 1, 2015 Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 6808... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11);... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-1... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-4... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
May 22, 2015 Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 22, 2015 Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA L... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
Apr 22, 2015 Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,00... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (ND... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only.... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx onl... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles,... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Co... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 6... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx o... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging O... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC:... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged i... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Onl... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (N... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt 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.