Lower riskDrug recall · FDA · Published April 30, 2026
Safecor Atomoxetine Capsules 10mg Mislabeled as 25mg - Label Error
Safecor Health recalls 10mg Atomoxetine capsules mislabeled as 25mg. This labeling error could lead to incorrect dosing. Consumers should check their product details and contact Safecor for guidance.
“Safecor Atomoxetine Capsules 10mg Mislabeled as 25mg - Label Error.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31321-safecor-atomoxetine-capsules-10mg-mislabeled-as-25mg-label-error. Based on FDA recall #D-0538-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0538-2026%22&limit=1).
The FDA announced on April 30, 2026, that Safecor Health, LLC is recalling Atomoxetine Capsules HCL, 10 mg due to a labeling mix-up hazard. The firm initiated this voluntary Class II recall after discovering the product was incorrectly labeled.
How to tell if you have it
Brand: Safecor
Product: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip
NDC: 64380-474-01
Lot #: 25530722
Distribution: TX only
The hazard
The recall addresses a labeling error where Atomoxetine HCl 25mg Capsules were incorrectly labeled as Atomoxetine HCl 10mg Capsules. The FDA's FAERS database contains 3,549 adverse-event reports naming this product, with 2,738 marked serious and 954 listing a death.
Context
GovInfoNow's records show Safecor Health, LLC has 11 other recalls on record since March 2, 2015. Other recent recalls of similar products include Otsuka ICU Medical Potassium Chloride Inj. 20mEq Label Error Recall (Oct. 29, 2025), ICU Medical Recalls Potassium Chloride Injection Due to Label Error (Oct. 29, 2025), and American Health Packaging Buprenorphine Tablets Recall: Label Mix-Up Hazard (Aug. 19, 2026).
How to tell if you have this one
Check for the product name 'Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip' with NDC 64380-474-01 and lot number 25530722. The capsules are sold by Safecor Health, LLC in cartons of 100.
Brand
Safecor
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the label that says 'Atomoxetine HCl 25mg Capsule' on a 10mg capsule. If present, the product is recalled.
Where it went and when
Where it was distributed
Distributed in Texas.
Listed by the agency
Not listed
FDA distribution: “TX only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0538-2026 (April 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0538-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.