Safecor Health recalls atomoxetine 10 mg capsules because some are actually 25 mg capsules
Some capsules labeled as atomoxetine 10 mg are actually 25 mg capsules, so a person could take a stronger dose than the label says.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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
- Company
- Safecor Health, LLC
- Hazard
- Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- Units
- 149 capsules
- Where sold
- TX only
- FDA classification
- Class II · Ongoing
- Classified by FDA
- May 18, 2026
- Recall started
- April 30, 2026
- FDA enforcement report
- May 27, 2026
- Identifiers
- Codes: Lot #: 25530722
- FDA recall number: D-0538-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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
- Reason for recall
- Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- Classification
- Class II (Ongoing)
- Distribution
- TX only
- Quantity
- 149 capsules
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