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Class II · ModerateActive recall

Duloxetine DR Capsules USP 60 mg

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

Does this affect you?
Check your lot numberLot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25
Where it was soldNationwide
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 recommended interim 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

Distributed by / forRising Pharm Holdings, Inc., East Brunswick, NJ
NDC57237-019-30
Show the full FDA record
Full product labelDuloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Recalling firmRising Pharma Holding, Inc.
DistributionNationwide
Quantity244,460 bottles
Recall initiated2024-12-30
Report date2025-01-15
Recall completed—
Recall numberD-0190-2025
ClassificationClass II
FDA statusOngoing
Origin on fileEast Brunswick NJ 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.