Focalin XR 5 mg Recall: Labeling Error
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Focalin XR 5 mg recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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
Which lot codes, UPCs or models are affected?
Lot VA0099422; Exp. Date June 30, 2028
- Agency record number
- D-0608-2026
- Product
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC…
- Recalling firm
- Sandoz Inc
- Quantity
- 7,803 bottles
- Distribution
- U.S. Nationwide
- Recall started
- June 1, 2026
- Report date
- June 24, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)