Duloxetine Delayed-Release Capsules — Class II drug recall D-0515-2026
Ongoing recall by Ajanta Pharma Ltd., reported 2026-05-13, distributed nationwide. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified
| Recall number | D-0515-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ajanta Pharma Ltd., Aurangabad, India |
| Recall initiated | 2026-04-29 |
| Classified | 2026-05-04 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 77,376 packages |
| Reason classes | cgmp, specification failure |
| NDC | 27241-0097, 27241-0097-05, 27241-0097-06, 27241-0097-10, 27241-0097-90, 27241-0098, 27241-0098-03, 27241-0098-09, 27241-0098-10, 27241-0099, 27241-0099-03, 27241-0099-40, 27241-0099-90, 27241-0164, 27241-0164-30 |
| Lot numbers | PA07434 |
| Expiration dates | 2026-05-20 |
Product
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
Reason for recall
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0515-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.