Desipramine Recall: Heritage 25 mg tablets (NDC 23155-579-01)
Announced 2025-11-05 · FDA
FDA recall involves Desipramine Hydrochloride Tablets, USP, 25 mg, 100-count bottle (NDC 23155-579-01), Rx only. The recall is due to CGMP deviations with N-Nitroso Desipramine impurity exceeding the permissible daily intake. About 2,418 bottles were distributed nationwide in the United States; affected lots are Lot#: 18036662 (Exp. 07/31/2026) and Lot#: 18037649 (Exp. 03/31/2027).
| Brand | Heritage Pharmaceuticals Inc |
|---|---|
| Product | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), 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. |
| Severity | moderate |
| Units affected | 8754 |
| Distribution | U.S. Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027 |
WHAT YOU SHOULD DO
- Do not use Desipramine Hydrochloride tablets from the affected lots.
- Check if your bottle has Lot 18036662 (exp 07/31/2026) or Lot 18037649 (exp 03/31/2027) and set it aside.
- Contact your pharmacist or healthcare provider for disposal or return instructions.
- Visit FDA.gov or the recall page for more information.
Other Heritage Pharmaceuticals Inc recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.