Information
Sandoz Inc Recalls Focalin XR (dexmethylphenidate HCl) 5 mg
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0608-2026Drug / Pharmaceutical
Sandoz Inc Recalls Focalin XR (dexmethylphenidate HCl) 5 mg
Sandoz Inc · Class III — Regulatory
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Sandoz Inc on June 1, 2026. Labeling: Incorrect or Missing Lot and/or Exp Date. This recall covers 7,803 bottles, distributed in U.S. Nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.