Browse Drug Recalls
120 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 120 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 120 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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, 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 | 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 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/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, 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/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 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 | 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 | 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. |
| May 15, 2013 | Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... | Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Apr 22, 2013 | Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-0... | Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was f... | Class II | Mylan Pharmaceuticals Inc. |
| Feb 26, 2013 | Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for... | Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identif... | Class III | Mylan Pharmaceuticals Inc. |
| Jan 30, 2013 | Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bot... | Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may ... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 16, 2013 | Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Myla... | Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet ... | Class II | Mylan Pharmaceuticals Inc. |
| Aug 7, 2012 | Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactu... | Cross Contamination w/Other Products: During stability testing chromatographic review revealed ex... | Class II | Mylan Pharmaceuticals Inc. |
| Jul 27, 2012 | Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured fo... | Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign... | Class II | Mylan Pharmaceuticals Inc. |
| Jun 29, 2012 | Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceu... | Failed USP Content Uniformity Requirements: OOS result reported on retained samples. | Class II | Mylan LLC. |
| Jun 28, 2012 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceutic... | Impurities/Degradation Products: Out of specification results for Related Compound during routine... | Class III | 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.