Quick Facts at a Glance
- Recall Date
- June 1, 2026
- Hazard Level
- HIGH
- Brands
- FOCALIN, Sandoz Inc
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- FOCALIN, Sandoz Inc
- Model numbers
- Lot VA0099422, Exp. Date June 30, 2028
- UPC codes
- 66758-235, 66758-240, 66758-239, 66758-241, 66758-242, 66758-237, 66758-236, 66758-238 +10 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 1, 2026
Reported by FDA DRUG
June 24, 2026
RecallRadar source check
June 30, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling: Incorrect or Missing Lot and/or Exp Date
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Sandoz Inc or your healthcare provider for guidance. Notification method: Letter
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Full 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. Generic: DEXMETHYLPHENIDATE HYDROCHLORIDE; Brand: FOCALIN. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Classification: Class III. Quantity: 7,803 bottles. Distribution: U.S. Nationwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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