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Atomoxetine HCl 10mg Capsules
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DRUG RECALLMODERATE

Atomoxetine HCl 10mg Capsules

Safecor is recalling Atomoxetine HCl 10mg Capsules (NDC 64380-474-01) because some cartons may contain 25mg capsules due to a labeling error.

What to do

Immediately check your medication packaging and the capsules inside. If you have received 25mg capsules in a carton labeled as 10mg, stop using the product and contact your pharmacist or healthcare provider for a replacement.

Posted
Updated
Recall No.
D-0538-2026
Agency
Firm
Safecor Health, LLC
Recall ID
98885
Status
ONGOING

Why it was recalled

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

How to identify it

UPC 25530722

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

Where it was sold

Distributed in US-TX.

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Editorial summary by Recall Canary · last updated 2026-05-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification