Browse Drug Recalls
1,056 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,056 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 1,056 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 30, 2012 | Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL,... | Impurities/Degradation Products: exceeded specification at 3 month stability testing | Class II | VistaPharm, Inc. |
| Apr 13, 2012 | Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... | Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... | Class II | West-ward Pharmaceutical Corp. |
| Apr 13, 2012 | Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... | Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... | Class II | West-ward Pharmaceutical Corp. |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Mar 29, 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets... | Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... | Class III | McKesson Packaging Services |
| Jul 6, 2011 | Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottl... | Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulos... | Class II | Bausch & Lomb, 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.