Duloxetine Delayed-Release Capsules 30 mg
Ajanta Pharma recalls Duloxetine 30 mg capsules due to N-nitroso-Duloxetine impurity above FDA limit.
Consumers should stop using the recalled capsules and return them to the place of purchase for a refund. Contact Ajanta Pharma USA Inc. at 1-866-217-1222 or recall@ajantapharma.com for further instructions.
Why it was recalled
Ajanta Pharma Ltd. 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, identified at the 12-month and 18-month long-term stability intervals.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Recall # |
|---|---|
| Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India | D-0514-2026 |
| Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. | D-0516-2026 |
| Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 | D-0515-2026 |
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification