Class II · ModerateActive recall

Duloxetine

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

Does this affect you?

Check your lot numberLot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027

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 above the proposed interim limit.

What to do

Check the lot number and expiry on your medicine against the recall above.
Talk to your pharmacist or doctor before changing anything — don't stop on your own.
Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTowa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

Brand name	DULOXETINE
Generic name	DULOXETINE HYDROCHLORIDE
Active ingredient(s)	DULOXETINE HYDROCHLORIDE
Distributed by / for	Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
NDC	51991-748-10

Show the full FDA record

Full product label	Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Recalling firm	Breckenridge Pharmaceutical, Inc
Distribution	US Nationwide.
Quantity	16,473 bottles
Recall initiated	2025-04-14
Report date	2025-04-30
Recall completed	—
Recall number	D-0387-2025
Classification	Class II
FDA status	Ongoing
Origin on file	Berlin CT United States

Duloxetine recalls Recent drug recalls Check 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.