Safecor Health, LLC recalls Atomoxetine Capsules HCL
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Apr 30, 2026
- Reported
- May 27, 2026
- Distribution
- TX only
- Status
- Ongoing
- Quantity
- 149 capsules
- Lot / codes
- Lot #: 25530722
- Company location
- Columbus, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0538-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0538-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.