FDA Drug recall D-0112-2026
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, I…
- FDA Drug
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, I… by Heritage Pharmaceuticals, citing CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0112-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-06 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Heritage Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Identifiers
| ndc | 23155-578-01 |
|---|---|
| ndc | 23155-579-01 |
| ndc | 23155-580-01 |
| ndc | 23155-581-01 |
| ndc | 23155-582-01 |
| ndc | 23155-583-25 |
| code_info | Lot#: 18035739, Exp. Date: 11/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.