FDAFDA · Food and drugs·Recall number D-0538-2026
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
Published May 27, 2026 · Recall initiated: April 30, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- ATOMOXETINE
- Manufacturer
- Safecor Health, LLC
- Distributor
- TX only
- UPC
- 0364380475019
- Lot
- Lot #: 25530722
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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