FDA recall, , Low risk
Sandoz Focalin XR Extended-Release Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date.
Summary by Recall Canary from the FDA notice
What happened
Sandoz Inc, of Princeton, New Jersey, recalled Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504, because of labeling with an incorrect or missing lot and/or exp date. The recall began June 1, 2026, and was added to the FDA's Enforcement Report on June 12, 2026. The product was distributed nationwide in the U.S.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle
- NDC
- 66758-235-31
- Lot code
- VA0099422
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- Sandoz IncPrinceton, New Jersey
- Hazard
- Labeling error
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99121
- Recall number
- D-0608-2026
- Quantity recalled
- 7,803 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
Summary updated
