Drug recall D-0514-2026
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 for recall
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.
Lots and codes
Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
Recall details
- Recalling firm
- Ajanta Pharma Ltd., Aurangabad
- Quantity
- 312,894 packs
- Distribution
- Nationwide within U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 29, 2026
Related products
- Duloxetine – drug information
- NDC 27241-099 Duloxetine · Duloxetine Hydrochloride 60 mg/1 · Ajanta Pharma USA Inc.
- NDC 27241-164 Duloxetine · Duloxetine Hydrochloride 40 mg/1 · Ajanta Pharma USA Inc.
- NDC 27241-097 Duloxetine · Duloxetine Hydrochloride 20 mg/1 · Ajanta Pharma USA Inc.
- NDC 27241-098 Duloxetine · Duloxetine Hydrochloride 30 mg/1 · Ajanta Pharma USA Inc.