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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 number90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Where it was soldU.S. 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: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

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 / forBreckenridge Pharmaceutical, Inc.
NDC51991-748-90
Show the full FDA record
Full product labelDuloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Recalling firmBreckenridge Pharmaceutical, Inc.
DistributionU.S. Nationwide
Quantity172,263 bottles
Recall initiated2025-10-09
Report date2025-11-05
Recall completed—
Recall numberD-0100-2026
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.