Exact FDA event identifier

Event 99121

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: June 01, 2026
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Sandoz Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0608-2026

Recall number: D-0608-2026
Initiated: June 01, 2026
Classification: Class III
Status: Ongoing
Recalling firm: Sandoz Inc
Quantity: 7,803 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Code information

Lot VA0099422; Exp. Date June 30, 2028

Distribution pattern

U.S. Nationwide