Limited official informationFDA Drug Enforcement ReportsRecall date: Jun 24, 2026

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LL...

Full official 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

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Identifiers to compare

NDC 66758-235-31
Lot VA0099422

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 3...	Lot VA0099422; Exp. Date June 30, 2028	7,803 bottles	D-0608-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Labeling: Incorrect or Missing Lot and/or Exp Date

Agency classification: Class III

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

U.S. Food and Drug Administration authoritative
openFDA Drug authoritative

Official scope

Distribution reported by the agency

U.S. Nationwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.