Atomoxetine Capsules Recalled Due to a Labeling Error

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for atomoxetine capsules HCL, 10mg. The affected batch has been identified as Lot 25530722, affecting 149 capsules.
• The recall was initiated by Safecor Health, LLC due to a labeling error, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Atomoxetine capsules are used to treat children and adults with attention-deficit hyperactivity disorder (ADHD).

The FDA has issued a Class II recall for atomoxetine capsules HCL, 10mg, affecting 149 capsules. This medication is being recalled by Safecor Health, LLC based in Columbus, Ohio. The recall was initiated on April 30, 2026, and received a Class II classification on May 18, 2026.

The recall was initiated due to a labeling error; atomoxetine 25mg capsules were incorrectly labeled as atomoxetine 10mg capsules. This deficiency affects Lot 25530722. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is low. Safecor Health sent out a public notice via e-mail; no public press release has been issued for this recall.

Atomoxetine is a prescription medication used to treat ADHD by increasing focus and attention while decreasing restlessness. Pharmacists should identify and quarantine Lot 25530722, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. May 27, 2026. Accessed May 27, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220081