Class II
Ongoing
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.
This recall is currently active, issued November 5, 2025. It was issued by Heritage Pharmaceuticals Inc.
- Company
- Heritage Pharmaceuticals Inc
- Recall Initiated
- October 6, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0107-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,979 bottles.
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Distribution
U.S. Nationwide.
Lot / Code Info
Lot#: 18036908, Exp. Date: 09/30/2026
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