FDA Drug recall D-0516-2026
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India…
- 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, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India… 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-0516-2026 |
| 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, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
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#: PA10734, Exp. Jun 2026. |
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-0516-2026%22
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