Drug & medication recalls Moderate risk

Safecor Health, LLC recalls Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…

Recall date
April 30, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0538-2026
FDA classification
Class II
Brand / firm
Safecor Health, LLC
Sold / distributed
TX only

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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

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