FDA Drugs recall ·
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per… recall
- Recall number
- D-0608-2026
- Date
- (initiated June 1, 2026)
- Company / brand
- Sandoz Inc
100 College Rd W, Princeton, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 7,803 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot VA0099422; Exp. Date June 30, 2028
Distribution
U.S. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0608-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.