FDA Drug recall D-0514-2026
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,…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of 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,… by Ajanta Pharma, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0514-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-29 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ajanta Pharma |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| ndc | 27241-097-06 |
|---|---|
| ndc | 27241-097-10 |
| ndc | 27241-097-90 |
| ndc | 27241-097-05 |
| ndc | 27241-098-03 |
| ndc | 27241-098-09 |
| ndc | 27241-098-10 |
| ndc | 27241-164-30 |
| ndc | 27241-099-03 |
| ndc | 27241-099-90 |
| ndc | 27241-099-40 |
| code_info | Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0514-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.