Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0451-2025

D-0451-2025 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
June 4, 2025
Initiation Date
February 28, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,696 bottles

Product Description

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

Reason for Recall

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Distribution Pattern

U.S. Nationwide

Code Information

Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26

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  • D-0662-2025 Class II — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: (September 17, 2025)
  • D-0021-2026 Class II — Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Es (September 3, 2025)
  • D-0583-2025 Class II — Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufact (August 8, 2025)
  • D-0578-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl (August 7, 2025)
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  • D-0577-2025 Class II — Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-16 (August 7, 2025)
  • D-0588-2025 Class II — Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by (August 6, 2025)