Class II
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
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- Recall number
- D-0538-2026
- Report date
- May 27, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Safecor Health, LLC
- Generic names
- ATOMOXETINE
- Brand names
- ATOMOXETINE
- Product NDCs
- 64380-472, 64380-473, 64380-474, 64380-475, 64380-476, 64380-477, 64380-478
Code and lot information
Lot #: 25530722
Distribution
TX only
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.