Focalin XR 5 mg Capsules
Sandoz is recalling Focalin XR 5 mg capsules due to missing or incorrect lot numbers and expiration dates on the product labels.
Check your medication bottle for the lot number and expiration date. If the information is missing or incorrect, contact your pharmacist or healthcare provider for guidance on returning the product.
Why it was recalled
Sandoz is recalling Focalin XR (dexmethylphenidate HCl) 5 mg extended-release capsules due to incorrect or missing lot numbers and expiration dates on the product labeling.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
- Recall #
- D-0608-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification