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Class II · ModerateActive recall

Atomoxetine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 25530722
Where it was soldTX only
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byStrides Pharma Science Limited
Brand nameATOMOXETINE
Generic nameATOMOXETINE
Active ingredient(s)ATOMOXETINE HYDROCHLORIDE
Distributed by / forSafecor Health, LLC
NDC64380-474-01
Show the full FDA record
Full product labelAtomoxetine 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
Recalling firmSafecor Health, LLC
DistributionTX only
Quantity149 capsules
Recall initiated2026-04-30
Report date2026-05-27
Recall completed—
Recall numberD-0538-2026
ClassificationClass II
FDA statusOngoing
Origin on fileColumbus OH United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.