Carvedilol Tablets — Class II drug recall D-137-2013
Terminated recall by Mylan Pharmaceuticals Inc., reported 2013-02-06, distributed nationwide. Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
| Recall number | D-137-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2013-01-16 |
| Classified | 2013-01-28 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 11,580 bottles |
| NDC | 00378-3633-05 |
| Lot numbers | 02/14, ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034 |
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 for recall
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
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-137-2013. 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.