Recall: D-0538-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-30Initiated

OngoingStatus

Safecor Health, LLCFirm

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

Reason

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

Distribution

TX only

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.