D-0538-2026Class II

Safecor Health, LLC

Recalling firm

Safecor Health, LLC

Product type

Drug

Status

Ongoing

Report date

2026-05-27

Distribution

TX only

Firm state

Product quantity

149 capsules

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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

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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. 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.