Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Ma...
FDA Recall #D-0107-2026 — Class II — October 6, 2025
Product Description
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), 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.
Recalling Firm
Heritage Pharmaceuticals Inc — East Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,979 bottles.
Distribution
U.S. Nationwide.
Code Information
Lot#: 18036908, Exp. Date: 09/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated