Recall
FDAHealthOctober 6, 2025

Heritage Pharmaceuticals Inc — Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 6, 2025

U.S. Nationwide.

What's affected?

Product
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
UPC
0323155579017
Lot code
18035574

Additional details

Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 5,882 bottles..

View original FDA notice →

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