FDA DrugsClass II
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: A...
Published: May 13, 2026Recall ID: D-0515-2026Category: drugsCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Aurangabad |
| Openfda › Upc › 1 | 0327241164309 |
| Openfda › Upc › 2 | 0327241099038 |
| Openfda › Upc › 3 | 0327241097065 |
| Openfda › Upc › 4 | 0327241098031 |
| Openfda › Unii | 9044SC542W |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 596926 |
| Openfda › Rxcui › 2 | 596930 |
| Openfda › Rxcui › 3 | 596934 |
| Openfda › Rxcui › 4 | 616402 |
| Openfda › Spl id | ae1a8c02-c1fc-474a-9411-cebecd99e339 |
| Openfda › Brand name | DULOXETINE |
| Openfda › Spl set id | 2dde979d-b6f8-41d1-96fb-325c75ea3a74 |
| Openfda › Package ndc › 1 | 27241-097-06 |
| Openfda › Package ndc › 2 | 27241-097-10 |
| Openfda › Package ndc › 3 | 27241-097-90 |
| Openfda › Package ndc › 4 | 27241-097-05 |
| Openfda › Package ndc › 5 | 27241-098-03 |
| Openfda › Package ndc › 6 | 27241-098-09 |
| Openfda › Package ndc › 7 | 27241-098-10 |
| Openfda › Package ndc › 8 | 27241-164-30 |
| Openfda › Package ndc › 9 | 27241-099-03 |
| Openfda › Package ndc › 10 | 27241-099-90 |
| Openfda › Package ndc › 11 | 27241-099-40 |
| Openfda › Product ndc › 1 | 27241-097 |
| Openfda › Product ndc › 2 | 27241-098 |
| Openfda › Product ndc › 3 | 27241-164 |
| Openfda › Product ndc › 4 | 27241-099 |
| Openfda › Generic name | DULOXETINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DULOXETINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Ajanta Pharma USA Inc. |
| Openfda › Application number | ANDA208706 |
| Openfda › Is original packager | true |
| Event id | 98785 |
| Address 1 | B-4/5/6 MIDC Industrial Area |
| Address 2 | Paithan |
| Code info | Lot#: PA07434, Exp. May 2026. |
| Postal code | N/A |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 77,376 packs. |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260429 |
| Initial firm notification | Letter |
| Center classification date | 20260504 |
Overview
- Recalling FirmAjanta Pharma Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within U.S