Heritage Pharmaceuticals Inc: Drug Recall
Recall #D-0111-2026 · 10/06/2025
Class II: Risk
Recall Details
- Recall Number
- D-0111-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Heritage Pharmaceuticals Inc
- Status
- Ongoing
- Date Initiated
- 10/06/2025
- Location
- East Brunswick, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,882 bottles.
Reason for Recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Product Description
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Distribution Pattern
U.S. Nationwide.
Other Recalls by Heritage Pharmaceuticals Inc
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.