Class II Drug D-0538-2026 Ongoing

FDA Class II recall: ADHD drug atomoxetine — 25mg mislabeled as "10mg," risking a dosing mix-up

Safecor Health, LLC ・Reported May 27, 2026

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

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).

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.

Atomoxetine (brand name Strattera) is a prescription medication used to treat attention-deficit/hyperactivity disorder (ADHD).

Why it matters: trusting the label is fundamental to medication use, and a strength mix-up undermines that foundation. If a product labeled "10mg" is actually 25mg, a patient dosing by the label could ingest 2.5× the intended amount. Strength mix-ups carry risks of overdose and side effects, so even a small quantity and a Class II rating cannot be dismissed. It illustrates how central packaging and labeling are to drug safety. Follow official FDA information and your pharmacy/provider's instructions for affected lots and actions (this article is general organization, not medical advice; consult your doctor or pharmacist about your medication).

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?

A prescription medication used to treat attention-deficit/hyperactivity disorder (ADHD) (brand name Strattera).

Why is a strength mislabel a problem?

Patients dose by the labeled strength. If 25mg is labeled "10mg," following the label means taking 2.5× the intended amount, risking overdose and side effects.

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#Drug#Class II#ADHD#Labeling mix-up

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