Heritage Pharmaceuticals recalls desipramine tablets over too much of a nitrosamine impurity
The tablets contain an impurity called N-Nitroso Desipramine at a level above the acceptable daily intake limit.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.; Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet…
- Company
- Heritage Pharmaceuticals Inc
- Hazard
- CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
- Units
- 8,754 bottles.; 3,750 bottles.; 6,979 bottles.
- Where sold
- U.S. Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 27, 2025
- Recall started
- October 6, 2025
- FDA enforcement report
- November 5, 2025
- Identifiers
- Codes: Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
- FDA recall number: D-0108-2026
- Codes: Lot#: 18035739, Exp. Date: 11/30/2025
- FDA recall number: D-0112-2026
- Codes: Lot#: 18036908, Exp. Date: 09/30/2026
- FDA recall number: D-0107-2026
- Codes: Lot#:18036713, Exp Date: 08/31/2026
- FDA recall number: D-0109-2026
- Codes: Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026
- FDA recall number: D-0111-2026
- Codes: Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027
- FDA recall number: D-0110-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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. | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. | Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
- Reason for recall
- CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
- Classification
- Class II (Ongoing)
- Distribution
- U.S. Nationwide.
- Quantity
- 8,754 bottles.; 3,750 bottles.; 6,979 bottles.; 5880 bottles.; 5,882 bottles.; 2,418 bottles.
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