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Drug FDA Class II Ongoing Mislabeling

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

Safecor Health, LLC Published May 27, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Safecor Health, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

ATOMOXETINE · 149 capsules

NDC: 64380-472, 64380-473, 64380-474, 64380-475, 64380-476, 64380-477, 64380-478, 64380-472-01, 64380-472-02, 64380-473-01, 64380-473-02, 64380-474-01, 64380-474-02, 64380-475-01, 64380-475-02, 64380-476-01, 64380-476-02, 64380-477-01, 64380-477-05, 64380-478-01, 64380-478-02
Code info: Lot #: 25530722

Affected areas

Texas

Timeline

  1. Initiated
    Apr 30, 2026
  2. Published
    May 27, 2026
Recall number
D-0538-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.