Atomoxetine Capsule
FDA Recall NDC 64380-474
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atomoxetine (NDC 64380-474). A significant event, classified as Class II, was initiated on Apr 30, 2026 by Strides Pharma Science Limited. The reported reason for this action was: "Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Apr 30, 2026
May 27, 2026
149 capsules
Recall Profile & Regulatory Data
Event ID
98885
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Safecor Health, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TX only
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
Batch or Lot Expiration Information
Lot# : 25530722
Affected Packages Involved in this Recall
64380-472-01Product
64380-472-02Product
64380-473-01Product
64380-473-02Product
64380-474-01Product
64380-474-02Product
64380-475-01Product
64380-475-02Product
64380-476-01Product
64380-476-02Product
64380-477-01Product
64380-477-05Product
64380-478-01Product
64380-478-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
