Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 13, 2013 | Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 1... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottl... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 1... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bott... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottle... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC ... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmac... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (ND... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bott... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Aug 23, 2013 | CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL ... | CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was... | Class II | Central Shared Services dba Parallon |
| Aug 8, 2013 | Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Phar... | CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good ma... | Class II | Marlex Pharmaceuticals, Inc. |
| Jun 7, 2013 | VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconsti... | CGMP Deviations: product was not manufactured under current good manufacturing practices which co... | Class II | Sagent Pharmaceuticals Inc |
| May 1, 2013 | CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed ... | cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled in... | Class II | Medicis Pharmaceutical Corp |
| Apr 9, 2013 | 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Wa... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: B... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Trav... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets ... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablet... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Mar 19, 2013 | Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for T... | CGMP Deviation; cotton coil is missing in some packaged bottles | Class III | Teva Pharmaceuticals USA, Inc. |
| Feb 22, 2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intraveno... | cGMP Deviation | Class II | Petnet Solution Inc |
| Feb 11, 2013 | Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Man... | cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practi... | Class II | Jubilant Cadista Pharmaceuticals Inc. |
| Feb 4, 2013 | Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonat... | CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was no... | Class II | Carib Import & Export, Inc. |
| Jan 30, 2013 | AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor,... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, M... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppress... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bo... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl o... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz.... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape F... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, 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.