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Class II · ModerateActive recall

Duloxetine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: PA07434, Exp. May 2026.
Where it was soldNationwide within U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameDULOXETINE
Generic nameDULOXETINE
Active ingredient(s)DULOXETINE HYDROCHLORIDE
Distributed by / forAjanta Pharma Ltd.
NDC27241-099-03
Show the full FDA record
Full product labelDuloxetine 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
Recalling firmAjanta Pharma Ltd.
DistributionNationwide within U.S
Quantity77,376 packs.
Recall initiated2026-04-29
Report date2026-05-13
Recall completed—
Recall numberD-0515-2026
ClassificationClass II
FDA statusOngoing
Origin on fileAurangabad India

Related

Duloxetine recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.