Safecor Health, Llc: Atomoxetine Capsules Hcl, 10 Mg Capsules In Unit Dose Foil Strip, Strips Are Packed In Cartons Of 100

Safecor Health is recalling Atomoxetine Capsules labeled as 10 mg that were actually filled with 25 mg capsules due to a labeling mix-up. The recall affects products distributed in Texas only. This is a prescription medication recall classified as Class II.

Recalling firm
Safecor Health, LLC
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.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-30
Status
Ongoing
Areas affected
TX
Distribution
TX only

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/5c3942a9-d298-4760-b688-58de50bc0e6c