Drug recall D-0112-2026

Class II Ongoing reported Nov 5, 2025

Product

Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Reason for recall

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Lots and codes

Lot#: 18035739, Exp. Date: 11/30/2025

Recall details

Recalling firm
Heritage Pharmaceuticals Inc, East Brunswick, NJ
Quantity
3,750 bottles.
Distribution
U.S. Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
October 6, 2025

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