Sandoz Inc recalls Focalin XR
- Recalling company
- Sandoz Inc
- Product
- 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
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jun 1, 2026
- Reported
- Jun 24, 2026
- Distribution
- U.S. Nationwide
- Status
- Ongoing
- Quantity
- 7,803 bottles
- Lot / codes
- Lot VA0099422; Exp. Date June 30, 2028
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0608-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0608-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.