Drug recall D-0110-2026

Class II Ongoing reported Nov 5, 2025

Product

Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), 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#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027

Recall details

Recalling firm
Heritage Pharmaceuticals Inc, East Brunswick, NJ
Quantity
2,418 bottles.
Distribution
U.S. Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
October 6, 2025

Related products