“Sandoz Focalin XR 5mg Capsules: Missing Lot/Exp Date Recall.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31248-sandoz-focalin-xr-5mg-capsules-missing-lot-exp-date-recall. Based on FDA recall #D-0608-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0608-2026%22&limit=1).
The FDA announced on June 1, 2026, that Sandoz Inc is recalling Focalin XR (dexmethylphenidate HCl) 5 mg extended-release capsules due to incorrect or missing lot and expiration dates on the labeling. The recall affects 7,803 bottles distributed nationwide.
Manufacturer: Societal CDMO Gainesville, LLC, Gainesville, GA 30504
The hazard
The recall is due to labeling errors where the lot number and/or expiration date are incorrect or missing. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Sandoz Inc has issued 29 other recalls since October 9, 2013. Recent Sandoz recalls include a September 5, 2025 Cyclophosphamide Injection recall for temperature excursion risk and an August 13, 2025 Ciprofloxacin Otic Suspension recall for temperature abuse risk. Other recent recalls of similar products include Haleon Parodontax Mouthwash Recall (December 26, 2025), American Regent Levocarnitine Injection Recall (April 16, 2026), and Kirkman Lidocaine Cream Recall (February 18, 2026).
How to tell if you have this one
Check for the NDC code 66758-235-31 on the product label. The lot number should be VA0099422 and the expiration date June 30, 2028.
Brand
Sandoz
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Label Details
Verify the lot number (VA0099422) and expiration date (June 30, 2028) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0608-2026 (June 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0608-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.