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FDAFDA · Food and drugs·Recall number D-0108-2026

Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Published November 5, 2025 · Recall initiated: October 6, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
DESIPRAMINE HYDROCHLORIDE
Manufacturer
Heritage Pharmaceuticals Inc
Distributor
U.S. Nationwide.
UPC
0323155579017
Lot
Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
Risk classification
Class II
Area (FDA)
drug
Country
United States

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