Atomoxetine Capsules HCL recall (Safecor Health, LLC)
DrugClass IIOngoing
Summary: Safecor Health, LLC is recalling 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: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
What is being recalled
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
Why
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
TX only (states named: Texas)
How to tell if yours is affected
Lot #: 25530722
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0538-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 30, 2026 |
| Reported | May 27, 2026 |
| Company | Safecor Health, LLC |
| Company location | Columbus, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 149 capsules |
More recalls from Safecor Health, LLC · all drug recalls · recalls from April 2026