FDA Drugs recall ·
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip… recall
- Recall number
- D-0538-2026
- Date
- (initiated April 30, 2026)
- Company / brand
- Safecor Health, LLC
4060 Business Park Dr Ste B, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 149 capsules
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 25530722
Distribution
TX only
States: Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0538-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.