Browse Drug Recalls

2,193 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,193 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 2,193 FDA drug recalls in NJ.

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DateProductReasonClassFirm
Jun 15, 2015 Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Lib... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 15, 2015 Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15... Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and ... Class II Liberty Drug & Surgical
Jun 4, 2015 Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ... Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro... Class III Actavis Inc
May 27, 2015 E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil po... Failed stability specifications:This recall has been initiated due to out of specification result... Class III Bracco Diagnostic Inc
May 22, 2015 Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 25... Failed Dissolution Specifications; exceeded specification at the 9 hour time point Class II Dr. Reddy's Laboratories, Inc.
May 22, 2015 Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, R... Failed Dissolution Specifications; exceeded specification at the 9 hour time point Class II Dr. Reddy's Laboratories, Inc.
May 13, 2015 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On... Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). Class III West-Ward Pharmaceutical Corp.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bot... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in ... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 6, 2015 Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
May 4, 2015 Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy R... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Apr 29, 2015 Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- c... Subpotent Drug Class II Janssen Pharmaceuticals, 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.
Apr 21, 2015 NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, ... Failed Dissolution Specification; 6 month time point Class II Alvogen, Inc
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

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.