Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0231-2025

D-0231-2025 Class II Ongoing

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

Recall Details

Product Type
Drugs
Report Date
February 26, 2025
Initiation Date
January 29, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70,032 bottles

Product Description

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

Reason for Recall

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Distribution Pattern

Nationwide within the U.S

Code Information

Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.

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  • D-0021-2026 Class II — Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Es (September 3, 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)