⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Sandoz Inc: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC,

DrugsSource: FDA (drug) · Date: 2026-06-24

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Sandoz Inc
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
Reason / hazard
Labeling: Incorrect or Missing Lot and/or Exp Date
Classification
Class III
Status
Ongoing
Distribution / sold at
U.S. Nationwide
Recall initiated
2026-06-01
Code info
Lot VA0099422; Exp. Date June 30, 2028
Product quantity
7,803 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Princeton
State
NJ
Country
United States
Event id
99121
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