Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1661-2012 | 06-14-2007 | Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9 Package NDCs: 60505-2502-1; 60505-2502-2; 60505-2502-3; 60505-2503-1; 60505-2503-2; 60505-2503-3 | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. | Apotex Corp. / 3063 | Class II | Terminated |
| D-040-2013 | 02-24-2006 | Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile. | Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins. | Merit Medical Systems, Inc / 2470 kits | Class I | Terminated |
