Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
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 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 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 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, 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, 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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, 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 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 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 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 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, 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 21, 2015 NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, ... Failed Dissolution Specification; 6 month time point Class II Alvogen, Inc
Apr 20, 2015 IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02,... Subpotent Drug: Low out-of-specification potency result of the drug product. Class III Akorn, Inc.
Apr 18, 2015 Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100... Failed Impurities/Degradation Specifications Class III Valeant Pharmaceuticals North America LLC
Apr 18, 2015 Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle,... Failed Impurities/Degradation Specifications Class III Valeant Pharmaceuticals North America LLC
Apr 17, 2015 Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.... Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time po... Class II Valeant Pharmaceuticals North America LLC
Apr 16, 2015 Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle, Products failed the Antimicrobial Effectiveness Test Class II Tarmac Products, Inc.
Apr 16, 2015 Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 ... Products failed the Antimicrobial Effectiveness Test. Class II Tarmac Products, Inc.
Apr 16, 2015 Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL) Products failed the Antimicrobial Effectiveness Test Class II Tarmac Products, Inc.
Apr 15, 2015 Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pai... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli... Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported f... Class III Sandoz, Inc
Apr 15, 2015 Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain ... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorpha... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Ma... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppres... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class II Reckitt Benckiser LLC
Apr 14, 2015 Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis... Subpotent Drug: Flurandrenolide is subpotent. Class III Actavis Laboratories
Apr 13, 2015 Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-6... Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... Class II Teva Pharmaceuticals USA
Apr 13, 2015 HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose In... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC

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.