D-0538-2026 Class II Ongoing
FDA drug recall D-0538-2026 was initiated by Safecor Health, LLC on April 30, 2026 and is designated Class II. Reason for recall: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. The recall status is ongoing. Affected quantity: 149 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- May 27, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149 capsules
Product Description
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.
Distribution Pattern
TX only
Code Information
Lot #: 25530722