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FDA · Drugs ·

Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip recall

Safecor Health, LLC recalled Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip on May 27, 2026 because of labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. It was sold in TX.

Why it was recalled

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

What's recalled

Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01

Quantity: 149 capsules

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Safecor Health, LLC, Columbus, OH
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
TX
TX only
Status
Ongoing
Recall number
D-0538-2026
Source
U.S. Food and Drug Administration

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