FDARecalled Jun 24, 2026 · #D-0608-2026
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
Class III — low health risk
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Labeling: Incorrect or Missing Lot and/or Exp Date Classification: Class III Distribution: U.S. Nationwide
Product details
- 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
- Type
- Drugs
- Manufacturer
- Sandoz Inc
- Model numbers
- VA0099422
- UPCs
- —