Atomoxetine HCl Capsules
Safecor Health is recalling Atomoxetine HCl capsules due to a labeling mix-up that may result in patients receiving an incorrect dosage.
Check your medication packaging and prescription label immediately. If you have received 25 mg capsules labeled as 10 mg, stop using the product and contact your pharmacist or healthcare provider for guidance.
Why it was recalled
Safecor Health is recalling specific lots of Atomoxetine HCl capsules due to a labeling mix-up where 25 mg capsules were incorrectly packaged and labeled as 10 mg capsules. This error poses a risk of patients receiving a higher dose than prescribed.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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
- 25530722
- Recall #
- D-0538-2026
Where it was sold
Distributed in Texas.
Official source
Other recent recalls from Safecor Health, LLC
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification