FDA Drug · D-0109-2026

Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Class II · Ongoing

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

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Affected lots / codes — check yours against thisLot#:18036713, Exp Date: 08/31/2026
Recalling firm
Heritage Pharmaceuticals Inc, East Brunswick, NJ
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
5880 bottles.
Distribution
U.S. Nationwide.
Recall initiated
October 6, 2025
Classified
October 27, 2025
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0109-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →