Duloxetine Delayed-Release Capsules 30 mg
Ajanta recalls Duloxetine 30 mg capsules over nitrosamine impurity above FDA limit.
Consumers should stop taking the recalled capsules and contact their healthcare provider for guidance on alternative treatment. Return the product to the place of purchase for a refund or contact Ajanta Pharma USA Inc. for further instructions.
Why it was recalled
Ajanta Pharma is recalling Duloxetine Delayed-Release Capsules, 30 mg, due to the presence of N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm, detected at the 12-month and 18-month long-term stability intervals. The impurity is a nitrosamine that may increase the risk of cancer with long-term exposure.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Duloxetine Delayed-Release Capsules
| Lot code | Strength | NDC / UPC | Recall # |
|---|---|---|---|
| PA10774, 2026 | 30 mg | NDC 27241-098-09, NDC 27241-098-03, NDC 27241-098-10 | D-0514-2026 |
| PA10734, 2026 | 20 mg | NDC 27241-097-06 | D-0516-2026 |
| PA07434, 2026 | 60 mg | NDC 27241-099-03 | D-0515-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification