Leflunomide tablets — Class II drug recall D-1661-2012
Terminated recall by Apotex Corp., reported 2012-09-05, distributed nationwide. Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
| Recall number | D-1661-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2007-06-14 |
| Classified | 2012-08-27 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 3,063 |
| Reason classes | potency |
| NDC | 60505-2502, 60505-2502-01, 60505-2502-02, 60505-2502-03, 60505-2503, 60505-2503-01, 60505-2503-02, 60505-2503-03 |
Product
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
Reason for recall
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1661-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.