Home / Recalls / Sandoz Inc / D-0608-2026

D-0608-2026 Class III Ongoing

Recalled by Sandoz Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
June 24, 2026
Initiation Date
June 1, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,803 bottles

Product Description

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

Reason for Recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Distribution Pattern

U.S. Nationwide

Code Information

Lot VA0099422; Exp. Date June 30, 2028

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