FDA Drugs recall ·
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle ( recall
- Recall number
- D-0108-2026
- Date
- (initiated October 6, 2025)
- Company / brand
- Heritage Pharmaceuticals Inc
1 Tower Center Blvd Ste 1700, East Brunswick, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8,754 bottles.
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
Distribution
U.S. Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0108-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.