Sandoz Inc recalls Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-releas
See all recalls from Sandoz Inc →Recalled Product
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
Hazard / Issue
Labeling: Incorrect or Missing Lot and/or Exp Date
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot VA0099422; Exp. Date June 30, 2028
✅ What Should You Do?
- 1Stop taking this medication and contact your doctor or pharmacist immediately.
- 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
- 3Check the lot number on your bottle or packaging against the recalled lots listed above.
- 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Focalin XR (dexmethylphenidate HCl) →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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