Safecor Health Atomoxetine Capsules HCL Recall: FDA Class II

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot #: 25530722

Where it was sold

TX only

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0538-2026
Classification: Class II
Status: Ongoing
Recall initiated: Apr 30, 2026
FDA report date: May 27, 2026
Quantity: 149 capsules
Recall type: Voluntary: Firm initiated
Recalling firm: Safecor Health, LLC

Original FDA data

Every field from FDA enforcement report D-0538-2026, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Ongoing
Country: United States
Event ID: 98885
Address: 4060 Business Park Dr Ste B
Code information: Lot #: 25530722
Postal code: 43204-5047
Report date: May 27, 2026
Product type: Drugs
Recall number: D-0538-2026
Classification: Class II
Recalling firm: Safecor Health, LLC
Product quantity: 149 capsules
Reason for recall: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: TX only
Recall initiation date: Apr 30, 2026
Initial firm notification: E-Mail
Center classification date: May 18, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0538-2026, published May 27, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Safecor Health Atomoxetine Capsules HCL Recall

Summary