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 |
|---|---|---|---|---|
| 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. |
| Feb 12, 2015 | Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, ... | CGMP Deviations: Product excipient was not re-tested at the appropriate date. | Class III | Apotex Inc. |
| Dec 4, 2014 | Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Dec 4, 2014 | Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H... | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... | Class III | K C Pharmaceuticals Inc |
| Oct 20, 2014 | Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane,... | cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lo... | Class III | Nanophase Technologies Corporation |
| Sep 22, 2014 | CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufa... | CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not ... | Class II | Physicians Total Care, Inc. |
| Aug 13, 2014 | PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx o... | CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several cr... | Class II | Fresenius Kabi USA, LLC |
| Jul 18, 2014 | Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP... | CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. | Class II | Spectrum Laboratory Products |
| Jul 17, 2014 | Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I... | CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. | Class II | SST Corporation |
| Jul 9, 2014 | Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for ... | cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients m... | Class II | Gyma Laboratories Of Amer,Inc |
| 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. |
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.