Recall
FDAHealthApril 30, 2026

Safecor Health, LLC — 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

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

Is this relevant to me?

Geography
TX
Source agency
FDA
Category
Health
Published
April 30, 2026

TX only

What's affected?

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
UPC
0364380475019
Lot code
25530722

Additional details

Lot #: 25530722

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 149 capsules.

View original FDA notice →

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