Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Apr 29, 2026
- Reported
- May 13, 2026
- Distribution
- Nationwide within U.S
- Status
- Ongoing
- Quantity
- 312,894 packs
- Lot / codes
- Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
- Company location
- Aurangabad
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0514-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0514-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.