Warning
Ajanta Pharma Ltd. Recalls Duloxetine Delayed-Release Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0516-2026Drug / Pharmaceutical
Ajanta Pharma Ltd. Recalls Duloxetine Delayed-Release Capsules
Ajanta Pharma Ltd. · Class II — Moderate Risk
Product Description
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.
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within U.S
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Ajanta Pharma Ltd. has recalled a pharmaceutical product that the FDA classified as Class II affecting 117,168 packs. The recall was initiated on April 29, 2026. 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. Distribution covered Nationwide within U.S. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.