FDA Drugs recall ·
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules… recall
- Recall number
- D-0516-2026
- Date
- (initiated April 29, 2026)
- Company / brand
- Ajanta Pharma USA Inc
B-4/5/6 MIDC Industrial Area, Aurangabad, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 117,168 packs
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Why was it 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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: PA10734, Exp. Jun 2026.
Distribution
Nationwide within U.S
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0516-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.