United StatesFocalin XR (dexmethylphenidate HCl) 5 mg, 30 extended‑release capsules per bottle, Rx only, NDC 66758-235-31, manufactured by Societal CDMO Gainesville, LLC, Lot VA0099422, Exp. Date June 30, 2028 — 7,803 bottles distributed nationwide in the U.S. — is being recalled. The recall was issued because of incorrect or missing lot and/or expiration date labeling.
What's being recalled
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
Recalling firm: Sandoz Inc, Princeton, NJ, United States.
How to identify it
Lot VA0099422; Exp. Date June 30, 2028
The hazard
Labeling: Incorrect or Missing Lot and/or Exp Date
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)