Focalin XR recall: Labeling Error
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC…
Why was Focalin XR recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot VA0099422; Exp. Date June 30, 2028
- 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 date
- June 24, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)