Carvedilol Tablets recalled over manufacturing violations
- Recall date
- January 22, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactu…
- Recall number
- D-0216-2025
- FDA classification
- Class II
- Brand / firm
- Glenmark Pharmaceuticals Inc., USA
- Sold / distributed
- Nationwide in the U.S
Why it was recalled
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Get recall alerts
Free email alert whenever Glenmark Pharmaceuticals Inc., USA has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Glenmark Pharmaceuticals Inc., USA