Focalin XR recall (Sandoz Inc)
DrugClass IIIOngoing
Summary: Sandoz Inc is recalling 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: Labeling: Incorrect or Missing Lot and/or Exp Date.
What is being recalled
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
Why
Labeling: Incorrect or Missing Lot and/or Exp Date
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lot VA0099422; Exp. Date June 30, 2028
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0608-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | June 1, 2026 |
| Reported | June 24, 2026 |
| Company | Sandoz Inc |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7,803 bottles |
More recalls from Sandoz Inc · all drug recalls · recalls from June 2026