Official recall notice

FDA DrugClass IINotable

Atomoxetine Capsules HCL Capsules Recall (May 2026)

Product: 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

Recall date
2026-05-27
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Verify with the official notice →
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