Reported Jun 24, 2026 · Ongoing
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal…
Sandoz Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Inc · 100 College Rd W · Princeton, NJ · 08540-6604
Is this the product you have?
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504
- NDC66758-235-31
- Lot codes and dates
Lot VA0099422Exp. Date June 302028
- Amount recalled
- 7,803 bottles
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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