← FDA ENFORCEMENT
D-0538-2026Class II

Safecor Health, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Safecor Health, LLC
Product type
Drug
Status
Ongoing
Report date
2026-05-27
Distribution
TX only
Firm state
OH
Product quantity
149 capsules
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

Lot #: 25530722

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →