Class II
Duloxetine 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.
- Recall number
- D-0515-2026
- Report date
- May 13, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Ajanta Pharma Ltd.
- Generic names
- DULOXETINE
- Brand names
- DULOXETINE
- Product NDCs
- 27241-097, 27241-098, 27241-164, 27241-099
Code and lot information
Lot#: PA07434, Exp. May 2026.
Distribution
Nationwide within U.S
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.