← FDA ENFORCEMENT
D-0216-2025Class II

Glenmark Pharmaceuticals Inc., USA

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Ongoing
Report date
2025-02-12
Distribution
Nationwide in the U.S
Firm state
NJ
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Product description

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.

Code / lot info

Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 10/2025; 17240220,17240240, Exp.: 01/2026; 17240459, Exp.: 02/2026 b) 17230814, Exp.: 03/2025; 17231392, Exp.:05/2025; 17232260, Exp.: 10/2025.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.