FDA Recall Carvedilol
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Carvedilol with NDC 0378-3633 was initiated on 10-21-2022 as a Class II recall due to failed tablet/capsule specifications: tablets exceeds specification for weight and thickness. The latest recall number for this product is D-0063-2023 and the recall is currently terminated as of 07-13-2023 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0063-2023 | 10-21-2022 | 11-23-2022 | Class II | 2,794 bottles | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 | Terminated |
| D-137-2013 | 01-16-2013 | 02-06-2013 | Class II | 11,580 bottles | 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. | Terminated |
What is the Enforcement Report?
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.