Sandoz

1 recall on record · Last recall: Jun 1, 2026

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Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Recall Timeline

Class IIIFDAJun 1, 2026

Sandoz — Labeling: Incorrect or Missing Lot and/or Exp Date

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 Labeling: Incorrect or Missing Lot and/or Exp Date

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