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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 # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Where it was soldUS Nationwide.
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 Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

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 byAsclemed USA, Inc.
Brand nameDULOXETINE
Generic nameDULOXETINE
Active ingredient(s)DULOXETINE HYDROCHLORIDE
Distributed by / forAsclemed USA Inc.
NDC76420-634-30
Show the full FDA record
Full product labelDuloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Recalling firmAsclemed USA Inc.
DistributionUS Nationwide.
Quantity50 bottles
Recall initiated2026-05-14
Report date2026-06-10
Recall completed—
Recall numberD-0555-2026
ClassificationClass II
FDA statusOngoing
Origin on fileTorrance CA United States

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.