Ajanta Pharma Ltd.: Duloxetine Delayed-release Capsules, 20 Mg
Recall Summary Ajanta Pharma is recalling Duloxetine Delayed-Release Capsules, 20 mg (NDC 27241-097-06) distributed nationwide because the medication contains higher-than-acceptable levels of a nitrosamine impurity called N-nitroso-Duloxetine. The impurity was detected during stability testing at 12 and 18 months. This is a prescription medication marketed by Ajanta Pharma USA Inc. and made in India.
- Recalling firm
- Ajanta Pharma Ltd.
- 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.
- 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/79824039-36ff-4520-83aa-13e0fca78d47