FDA Drug recall D-137-2013
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-…
- FDA Drug
- Class II
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class II recall of Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-… by Mylan Pharmaceuticals, citing failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-137-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-16 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
Reason
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Identifiers
| upc | 303783633053 |
|---|---|
| code_info | Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14 |
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-137-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.