Recall Record: Class III Recall: FOCALIN by Sandoz Inc

Key facts

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is Sandoz Inc and the affected product is described in FDA's record as: 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. FDA's stated reason for the recall is: Labeling: Incorrect or Missing Lot and/or Exp Date. The recall is tracked under FDA recall number D-0608-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 -- and the recall number D-0608-2026. If it matches, stop using or distributing it and contact Sandoz Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

NOVARTIS’s FDA history

Argus HQ has recorded 4 total FDA actions tied to NOVARTIS: 0 warning letters, 1 recall, 3 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Sandoz Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Sandoz Inc, including 1 recall and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number D-0608-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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