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FDAClass III · Drug · Recalled June 24, 2026

Focalin XR (dexmethylphenidate HCl) 5 mg recall — Sandoz Inc

Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0608-2026
Brand
Sandoz
Classification
Class III
Units affected
7,803 bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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

Affected products

Companies & origin

Recalling firm location
Princeton, NJ, United States
Firm address
100 College Rd W, 08540-6604

Identifying details (verbatim from the notice)

Product codes / lots
Lot VA0099422; Exp. Date June 30, 2028
Distribution
U.S. Nationwide
Firm notified the public via
Letter
FDA event ID
99121
Recall initiated
June 1, 2026
FDA classified
June 22, 2026
FDA report date
June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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