Recalling firm
Ajanta Pharma Ltd.
Product type
Drug
Status
Ongoing
Report date
2026-05-13
Distribution
Nationwide within U.S
Product quantity
77,376 packs.
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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.
Product description
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
Code / lot info
Lot#: PA07434, Exp. May 2026.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.