FDA recall D-0608-2026

Product

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

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-06-01

Report date

2026-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2026