Duloxetine Recall: Ajanta Pharma USA DR Capsules 30 mg
Announced 2026-07-29 · FDA
Asclemed USA Inc. is recalling 50 bottles of Duloxetine DR Capsules, 30 mg, 30-count bottles, distributed nationwide in the US (Lot # 050725G-30 and 050725F-30; Exp 06/30/2026). The recall is due to CGMP deviations and the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. No corrective action information is provided.
| Brand | Asclemed USA Inc. |
|---|---|
| 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. |
| Severity | moderate |
| Units affected | 18 |
| Distribution | US Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026 |
WHAT YOU SHOULD DO
- If you have any recalled lots (Lot # 050725G-30 or 050725F-30) with expiry 06/30/2026, stop taking the product and contact your pharmacist or healthcare provider.
- Do not use any more of the recalled bottles; follow disposal or return instructions from your pharmacist or the recall notice.
- Keep the product packaging and lot number information until you have received further instructions from your healthcare provider or the recall notice.
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.