HIGHFDA DRUG

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

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

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
April 30, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 30, 2026
Hazard Level
HIGH
Brands
ATOMOXETINE, Strides Pharma Science Limited
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
ATOMOXETINE, Strides Pharma Science Limited
Model numbers
Lot #: 25530722
UPC codes
64380-472, 64380-473, 64380-474, 64380-475, 64380-476, 64380-477, 64380-478, 64380-472-01 +9 more
Where affected
TX

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 30, 2026

  2. Reported by FDA DRUG

    May 27, 2026

  3. RecallRadar source check

    June 3, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Safecor Health, LLC or your healthcare provider for guidance. Notification method: E-Mail

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Full 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. Generic: ATOMOXETINE; Brand: ATOMOXETINE. Reason: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.. Classification: Class II. Quantity: 149 capsules. Distribution: TX only

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot #: 25530722
UPC Codes
64380-472
64380-473
64380-474
+14 more
Affected States
TX
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE