FDA Class II recall: ADHD drug atomoxetine — 25mg mislabeled as "10mg," risking a dosing mix-up
Drug repackager Safecor Health recalled atomoxetine HCl capsules where a 25mg product was mistakenly labeled "10mg." The FDA classified it Class II. Trusting the label could lead a patient to take 2.5× the intended dose.
Recall overview (primary data)
- ClassificationClass II
- Product typeDrug
- Recalling firmSafecor Health, LLC
- ReasonLabeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- DistributionTX only
- Recall initiated2026-04-30
Key points
- Atomoxetine (ADHD) capsules: a 25mg product mislabeled as "10mg"
- FDA classified it Class II (D-0538-2026, reported May 27, 2026, ongoing)
- Trusting the label could mean taking 2.5× the intended dose
- Distribution Texas only; 149 capsules; repackager Safecor Health
- Drug strength labeling is central to safety — a mix-up risks overdose
1A Class II drug recall
The U.S. FDA classified Safecor Health, LLC's drug recall as Class II (use may cause temporary or medically reversible adverse health consequences, with a low probability of serious harm) — recall number D-0538-2026, reported May 27, 2026, status ongoing (firm-initiated).
2A strength labeling mix-up
The affected product is atomoxetine HCl capsules (unit-dose foil strips, strips packed in cartons of 100, prescription-only). The reason is a label mix-up: a 25mg capsule was incorrectly labeled as 10mg. The recall was initiated April 30, 2026; distribution was Texas (TX) only; quantity 149 capsules. Safecor is a drug repackaging firm.
3What atomoxetine is
Atomoxetine (brand name Strattera) is a prescription medication used to treat attention-deficit/hyperactivity disorder (ADHD).
Why it matters
An example of a drug strength-mislabeling risk that bears directly on dosing. It highlights packaging/label control and helps patients and pharmacies identify affected lots (consult a doctor or pharmacist about use).
FAQ
What is atomoxetine?
Why is a strength mislabel a problem?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0538-2026