Atomoxetine Capsules HCl 10 mg Recall: Labeling Error
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.…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Atomoxetine Capsules HCl 10 mg recalled?
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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
Which lot codes, UPCs or models are affected?
Lot #: 25530722
- Agency record number
- D-0538-2026
- 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.…
- Recalling firm
- Safecor Health, LLC
- Quantity
- 149 capsules
- Distribution
- TX only
- Recall started
- April 30, 2026
- Report date
- May 27, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)