FDA Drug recall D-1661-2012
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apote…
- FDA Drug
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apote… by Apotex, citing subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1661-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2007-06-14 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
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
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Identifiers
| ndc | 60505-2502-1 |
|---|---|
| ndc | 60505-2502-2 |
| ndc | 60505-2502-3 |
| ndc | 60505-2503-1 |
| ndc | 60505-2503-2 |
| ndc | 60505-2503-3 |
| code_info | Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1661-2012%22
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