Recalls / Class II
Class IID-0108-2026
Product
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.
- Brand name
- Desipramine Hydrochloride
- Generic name
- Desipramine Hydrochloride
- Active ingredient
- Desipramine Hydrochloride
- Route
- Oral
- NDCs
- 23155-578, 23155-579, 23155-580, 23155-581, 23155-582, 23155-583
- FDA application
- ANDA207433
- Affected lot / code info
- Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
Why it was recalled
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recalling firm
- Firm
- Heritage Pharmaceuticals Inc
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 8,754 bottles.
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2025-10-06
- FDA classified
- 2025-10-27
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0108-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.