Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDM
Summary
The FDA issued a Class III for Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottl by Sandoz Inc. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date.
Details
Source
Drug Recall
External ID
D-0608-2026
Action Date
2026-06-24
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot VA0099422; Exp. Date June 30, 2028
Quantity Affected: 7,803 bottles
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-01
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 195 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Sandoz Inc has 19 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sandoz Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sandoz Inc have FDA actions?
Sandoz Inc has 19 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0608-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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