Class II · ModerateRecall completed

Duloxetine Delayed-Release Capsules USP

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

Does this affect you?

Check your lot numberLot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025

Where it was soldNationwide 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 Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake 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

Distributed by / for	Major Pharmaceuticals, Indianapolis, IN 46268 USA
NDC	0904-7043-04

Show the full FDA record

Full product label	Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Recalling firm	The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Distribution	Nationwide within the United States
Quantity	a) 6408 boxes and b)1488 boxes
Recall initiated	2025-01-13
Report date	2025-02-05
Recall completed	2026-03-05
Recall number	D-0212-2025
Classification	Class II
FDA status	Terminated
Origin on file	La Vergne TN 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.