Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 23, 2012 | ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alc... | Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material tha... | Class II | Carefusion 213, Llc |
| Apr 16, 2012 | Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy ... | Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap du... | Class II | Bracco Diagnostics Inc |
| Nov 8, 2011 | ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative S... | Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (op... | Class II | Carefusion 213, Llc |
| 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. |
| Jun 22, 2011 | Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose ... | Lack of Assurance of Sterility | Class II | Nephron Pharmaceuticals Corp. |
| Feb 24, 2006 | Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution,... | Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be conta... | Class I | Merit Medical Systems, 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.