Focalin Capsule, Extended Release
FDA Recall NDC 66758-238
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Focalin (NDC 66758-238). A significant event, classified as Class III, was initiated on Jun 01, 2026 by Sandoz Inc. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Labeling: Incorrect or Missing Lot and/or Exp Date
Jun 01, 2026
Jun 24, 2026
7,803 bottles
Recall Profile & Regulatory Data
Event ID
99121
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
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
Batch or Lot Expiration Information
Lot# Lot VA0099422; Exp. Date June 30, 2028
Affected Packages Involved in this Recall
66758-240-01Product
66758-240-31Product
66758-239-01Product
66758-239-31Product
66758-241-01Product
66758-241-31Product
66758-242-01Product
66758-242-31Product
66758-237-01Product
66758-237-31Product
66758-235-01Product
66758-235-31Product
66758-236-01Product
66758-236-31Product
66758-238-01Product
66758-238-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
