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Class II · ModerateRecall completed

Duloxetine

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

Does this affect you?
Check your lot numberLot #: 220128, Exp. Date 12/2024
Where it was soldProduct was distributed nationwide within the United States
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 byBreckenridge Pharmaceutical, Inc.
Brand nameDULOXETINE
Generic nameDULOXETINE HYDROCHLORIDE
Active ingredient(s)DULOXETINE HYDROCHLORIDE
Distributed by / forBPI
NDC51991-746-05
Show the full FDA record
Full product labelDuloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Recalling firmBreckenridge Pharmaceutical, Inc
DistributionProduct was distributed nationwide within the United States
Quantity7,107 bottles
Recall initiated2024-10-10
Report date2024-10-23
Recall completed—
Recall numberD-0009-2025
ClassificationClass II
FDA statusCompleted
Origin on fileBerlin CT 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.