Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 9, 2014 | Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medici... | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... | Class II | Gyma Laboratories Of Amer,Inc |
| Jul 9, 2014 | Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medi... | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... | Class II | Gyma Laboratories Of Amer,Inc |
| Jul 9, 2014 | Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Prep... | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... | Class II | Gyma Laboratories Of Amer,Inc |
| Jun 26, 2014 | Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756... | CGMP Deviations: These products are being recalled because they were manufactured with active pha... | Class II | Caraco Pharmaceutical Laboratories, Ltd. |
| Jun 26, 2014 | Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756... | CGMP Deviations: These products are being recalled because they were manufactured with active pha... | Class II | Caraco Pharmaceutical Laboratories, Ltd. |
| Mar 24, 2014 | INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In ... | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Class II | Teva Pharmaceuticals USA |
| Mar 24, 2014 | METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In IN... | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Class II | Teva Pharmaceuticals USA |
| Mar 24, 2014 | GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottl... | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Class II | Teva Pharmaceuticals USA |
| Mar 24, 2014 | INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b)... | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. | Class II | Teva Pharmaceuticals USA |
| Jan 24, 2014 | Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Di... | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved ... | Class II | Teva Pharmaceuticals USA |
| Jan 24, 2014 | Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Su... | CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate an... | Class II | Teva Pharmaceuticals USA |
| Jan 24, 2014 | Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Onl... | CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved... | Class II | Teva Pharmaceuticals USA |
| Jan 24, 2014 | Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Dis... | CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved m... | Class II | Teva Pharmaceuticals USA |
| Oct 7, 2013 | Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturi... | CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current g... | Class II | Betachem, Inc. |
| Sep 26, 2013 | CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card.... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 26, 2013 | LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 bl... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 17, 2013 | Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) u... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 17, 2013 | Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) ... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 17, 2013 | Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) ... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 13, 2013 | Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmace... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4... | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... | Class II | Mylan Pharmaceuticals Inc. |
| Sep 13, 2013 | Amlodipine Besylate Tablets, USP 10 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 | 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 |
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.