Desipramine Hydrochloride Tablets — Class II drug recall D-0110-2026
Ongoing recall by Heritage Pharmaceuticals Inc, reported 2025-11-05, distributed nationwide. CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
| Recall number | D-0110-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals Inc, East Brunswick, NJ, United States |
| Recall initiated | 2025-10-06 |
| Classified | 2025-10-27 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 2,418 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 23155-0578, 23155-0578-01, 23155-0579, 23155-0579-01, 23155-0580, 23155-0580-01, 23155-0581, 23155-0581-01, 23155-0582, 23155-0582-01, 23155-0583, 23155-0583-25 |
| Lot numbers | 18036662, 18037649 |
| Expiration dates | 2026-07-31, 2027-03-31 |
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 for recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0110-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.