Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets
- Recalling company
- Heritage Pharmaceuticals Inc
- Product
- 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.
- Reason
- CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 6, 2025
- Reported
- Nov 5, 2025
- Distribution
- U.S. Nationwide.
- Status
- Ongoing
- Quantity
- 5,882 bottles.
- Lot / codes
- Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026
- Company location
- East Brunswick, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0111-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0111-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.