Focalin XR Recalled Due to Incorrect Labeling

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for Focalin XR (dexmethylphenidate HCl), 5 mg. The affected batch has been identified as Lot VA0099422 (expires June 2028), affecting 7803 bottles.
• The recall was initiated by Sandoz Inc due to incorrect labeling, a quality issue that is not likely to cause adverse health consequences.
• Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

The FDA has issued a Class III recall for Focalin XR (dexmethylphenidate HCl), 5 mg, affecting 7803 bottles. This medication is manufactured by Societal CDMO Gainesville, LLC based in Gainesville, Georgia. The recall was initiated by Sandoz Inc on June 1, 2026, and received a Class III classification on June 22, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated due to incorrect labeling of the product; the container has either an incorrect or missing Lot number and/or expiration date. This deficiency affects Lot VA0099422, which will expire in June 2028. Sandoz Inc sent out a public notice via letter; no press release has been issued for this recall.

Dexmethylphenidate is a prescription medication used to treat children and adults with ADHD by increasing attention and decreasing restlessness. Pharmacists should identify and quarantine Lot VA0099422, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. June 24, 2026. Accessed June 24, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220914