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Browse Drug Recalls

45 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 45 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 45 FDA drug recalls.

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DateProductReasonClassFirm
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.
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.
Apr 22, 2015 Lisinopril Tablets USP, 40 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 Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bott... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged i... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manuf... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 ... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Apr 22, 2015 Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II Wockhardt Usa Inc.
Mar 12, 2015 Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-0... Failed Tablet/Capsule Specifications: out of specification for thickness. Class II Wockhardt Usa Inc.
Jul 24, 2014 Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-c... Failed Dissolution Specifications: Dissolution failures found during testing of control samples a... Class II Wockhardt Usa Inc.
Jul 14, 2014 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, R... Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzo... Class III Wockhardt Usa Inc.
Apr 17, 2014 Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long te... Class III Wockhardt Usa Inc.
Apr 10, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle,... Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. Class II Wockhardt Usa Inc.
Apr 1, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, R... Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. Class II Wockhardt Usa Inc.
Nov 27, 2013 Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle,... Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit ... 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.