← FDA ENFORCEMENT
D-0578-2025Class II

Glenmark Pharmaceuticals Inc., USA

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Ongoing
Report date
2025-08-20
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
6,432 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Product description

Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05

Code / lot info

Lot#:19243202, Exp: 7/31/2026.

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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.