ATOMOXETINE
Recalling Firm / Manufacturer: Safecor Health, LLC
(Columbus, OH, United States)
FDA Recall Number: D-0538-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ATOMOXETINE
Generic Name
ATOMOXETINE
Active Substance(s)
Atomoxetine Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
64380-472
Total Quantity Recalled
149 capsules
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
May 27, 2026
Firm Initiation Date
April 30, 2026
FDA Classification Date
May 18, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 25530722
Distribution Information
Geographic scope of affected shipments
TX only
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0538-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508602UTCC