Why it was recalled
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0108-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 6, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 8,754 bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0108-2026, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97770
- Address
- 1 Tower Center Blvd Ste 1700
- Code information
- Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
- Postal code
- 08816-1145
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0108-2026
- Classification
- Class II
- Recalling firm
- Heritage Pharmaceuticals Inc
- Product quantity
- 8,754 bottles.
- Reason for recall
- CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Oct 6, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2025