Desipramine Recall: Heritage 25 mg tablets (NDC 23155-579-01)
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027 |
|---|---|
| Lot / date codes | Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.