Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Product description
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
Lot numbers, UPCs & expiration codes
Lot VA0099422; Exp. Date June 30, 2028
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0608-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 1, 2026
- FDA report date
- Jun 24, 2026
- Quantity
- 7,803 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0608-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99121
- Address
- 100 College Rd W
- Code information
- Lot VA0099422; Exp. Date June 30, 2028
- Postal code
- 08540-6604
- Report date
- Jun 24, 2026
- Product type
- Drugs
- Recall number
- D-0608-2026
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 7,803 bottles
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jun 1, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 22, 2026