FDA-Drug2026-05-27Class IIMISBRANDING
Safecor Health atomoxetine capsules recalled for incorrect strength labeling
What this means
Safecor Health distributed atomoxetine 25 mg capsules that were labeled as 10 mg capsules. This labeling error affects one lot distributed in Texas. The mislabeling could result in patients taking a higher dose than prescribed.
- Check if you have atomoxetine from Safecor Health with lot #25530722.
- Do not take the medication if you have this lot.
- Contact your pharmacy or prescriber immediately for guidance on your prescription.
- Return the medication to your pharmacy.
The agency's original wording
Hazard
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Intended for
Adults
Illnesses reported
None reported
Sold states
TX only
Affected count
149 capsules
Manufactured in
4060 Business Park Dr Ste B, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0538-2026Want us to check the next one for you?
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