D-0516-2026 Class II Ongoing
FDA drug recall D-0516-2026 was initiated by Ajanta Pharma Ltd. on April 29, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 117,168 packs.
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2026
- Initiation Date
- April 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117,168 packs
Product Description
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 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.
Distribution Pattern
Nationwide within U.S
Code Information
Lot#: PA10734, Exp. Jun 2026.