Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

FDA recall notice · announced November 23, 2022 · Viatris

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05

Reason for recall

Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 3150116, Exp 2/2025
Quantity: 2,794 bottles
Status: Terminated
Products in this recall event:
- Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 (D-0063-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.