Focalin recalls

Focalin products have been recalled 1 time, most recently on 24 Jun 2026. The recalling company is usually Sandoz.

Total recalls1since 2026
Last 12 months1reported
Class I00% of total
Ongoing1latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 0 0%Class III 1 100%

Why focalin is recalled

Companies

Product types

By year

Ongoing focalin recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIFocalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalinSandozOtherNationwide

All focalin recalls, newest first

1 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIFocalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalinSandozOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.