Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot
Summary
The FDA issued a Class II for Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by Glenmark Pharmaceuticals Inc., USA. Reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm.
Details
Source
Drug Recall
External ID
D-0587-2025
Action Date
2025-08-20
Status
Ongoing
Category
drug
Product Description
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Lot/Code Info: Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026
Quantity Affected: 17, 496 bottles
Reason for Recall
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-06
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0587-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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