FDA Drug recall D-0555-2026
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Markete…
- FDA Drug
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Markete… by Asclemed Usa, citing CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0555-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-14 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Asclemed Usa |
| Distribution | US |
Product
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Reason
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Identifiers
| ndc | 76420-633-20 |
|---|---|
| ndc | 76420-633-30 |
| ndc | 76420-633-60 |
| ndc | 76420-633-90 |
| ndc | 76420-633-01 |
| ndc | 76420-633-05 |
| ndc | 76420-633-00 |
| ndc | 76420-634-20 |
| ndc | 76420-634-30 |
| ndc | 76420-634-60 |
| ndc | 76420-634-90 |
| ndc | 76420-634-01 |
| ndc | 76420-634-00 |
| ndc | 76420-636-20 |
| ndc | 76420-636-30 |
| ndc | 76420-636-60 |
| ndc | 76420-636-90 |
| ndc | 76420-636-01 |
| ndc | 76420-623-20 |
| ndc | 76420-623-30 |
| ndc | 76420-623-60 |
| ndc | 76420-623-90 |
| ndc | 76420-623-01 |
| ndc | 76420-623-00 |
| code_info | Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026 |
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-0555-2026%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.