Duloxetine Recall: Ajanta Pharma USA DR Capsules 30 mg
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026 |
|---|---|
| Lot / date codes | Lot: 070126X1, Exp. 12/31/2027. |
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 duloxetine recalls
- Duloxetine Recall: Ajanta Pharma USA 60 mg capsules · 2026-07-01
- Duloxetine Recall: Cymbalta 30 mg capsules (30 & 60 caps) · 2026-07-01
- Duloxetine Recall: Breckenridge 3,591 bottles · 2026-06-17
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.