Recall RadarDuloxetine 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
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.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Ajanta Pharma Ltd. — Aurangabad
- Severity
- Class II — moderate
- Reported
- May 13, 2026
- Quantity
- 77,376 packs.
- Recall number
- D-0515-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide within U.S
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