Duloxetine Delayed-Release Capsules recall
Ajanta Pharma Ltd. recalled Duloxetine Delayed-Release Capsules on May 13, 2026 because of 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. It was sold nationwide.
Why it was recalled
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.
What's recalled
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
Quantity: 312,894 packs
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Ajanta Pharma Ltd., Aurangabad
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide within U.S - Status
- Ongoing
- Recall number
- D-0514-2026
- Source
- U.S. Food and Drug Administration
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