Ajanta Pharma Ltd.: Duloxetine Delayed-release Capsules, 30 Mg
Recall Summary Ajanta Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg distributed nationwide because the medication contains higher-than-acceptable levels of a chemical impurity called N-nitroso-Duloxetine. The affected products were distributed across all U.S. states and come in three package sizes: 30 capsules, 90 capsules, and 1,000 capsules. This recall was triggered by testing that found the impurity exceeded FDA limits during long-term stability testing.
- Recalling firm
- Ajanta Pharma Ltd.
- 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.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-29
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3d869343-fa7c-4d57-a9f0-b6e6968f3a30