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Safecor Atomoxetine 10mg Recall

Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, O

Updated April 30, 2026

Safecor Health is recalling Atomoxetine Capsules labeled as 10 mg because some capsules actually contain 25 mg due to a labeling error. Taking the wrong dose of this ADHD medication can cause serious health problems.

Is the Safecor Health, LLC recalled? Yes. This product was recalled by FDA on April 30, 2026. Details below.

What is recalled

Atomoxetine Capsules HCl, 10 mg in unit dose foil strips packed in cartons of 100. NDC: 64380-474-01. Packaged by Safecor, Columbus, OH 43204. Some capsules are mislabeled and actually contain 25 mg instead of 10 mg.

Am I affected

You're affected if you have a prescription bottle labeled "Atomoxetine HCl 10 mg Capsule" with NDC 64380-474-01, packaged by Safecor Health, LLC in Columbus, OH. Check your prescription label and the carton for this NDC number.

What to do right now

Stop taking this medication. Contact your pharmacy or doctor immediately before taking any more doses. Do not discard the capsules without speaking to a healthcare provider first, as they may need to see them for verification.

The hazard

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

Brands affected

Safecor Health, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0538-2026
Classification
Class II
Recalled
April 30, 2026
Read the official notice

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