FDA recall, , Moderate risk
Safecor Health Atomoxetine Capsules
Atomoxetine Capsules HCL, 10 mg Capsules are mislabeled as 25 mg capsules.
Summary by Recall Canary from the FDA notice
What happened
Safecor Health, LLC, of Columbus, Ohio, recalled Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204, because a label mix-up caused Atomoxetine HCl 25mg Capsule to be incorrectly labeled as Atomoxetine HCl 10mg Capsule. The recall began April 30, 2026, and was added to the FDA's Enforcement Report on May 18, 2026.
The product was distributed in Texas only. The recall involved 149 capsules.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC or UPC is listed.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Atomoxetine Capsules HCL, 10 mg Capsules
- NDC
- 64380-474-01
- UPC
- 25530722
Recall details
- Company began the recall
- Sold in
- Company
- Safecor Health, LLCColumbus, Ohio
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98885
- Recall number
- D-0538-2026
- Quantity recalled
- 149 capsules
All recalls from Safecor Health, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
