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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 240539C, Exp 1/31/2027
Where it was soldNJ, AZ, IN
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 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

Made byTowa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands foreign manufacturer
Brand nameDULOXETINE
Generic nameDULOXETINE HYDROCHLORIDE
Active ingredient(s)DULOXETINE HYDROCHLORIDE
Distributed by / forQuallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands
NDC82009-032-10
Show the full FDA record
Full product labelDuloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Recalling firmBreckenridge Pharmaceutical, Inc.
DistributionNJ, AZ, IN
Quantity1,856 bottles
Recall initiated2025-07-25
Report date2025-08-20
Recall completed—
Recall numberD-0580-2025
ClassificationClass II
FDA statusOngoing
Origin on fileBerkeley Heights 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.