Sandoz recalls Focalin XR 5mg capsules due to missing lot and expiration dates. Affected units may pose safety risks if not properly labeled.
Labeling: Incorrect or Missing Lot and/or Exp Date
Sandoz is recalling Focalin XR 5mg capsules because they may have missing or incorrect lot and expiration dates. This could lead to safety issues if the medication is not properly labeled.
Incorrect or missing lot and expiration dates on medication labels can cause confusion about the product's safety and effectiveness. This may lead to improper use or potential safety risks if the medication is not properly tracked.
Prescription holders of Focalin XR 5mg capsules with missing or incorrect lot and expiration dates. Those who have the specific NDC 66758-235-31 product are most at risk.
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.
Verify the lot number (VA0099422) and expiration date (June 30, 2028) on the product label.
The recall is due to missing or incorrect lot and expiration dates, not safety issues with the medication itself. Proper labeling is required for safe use.
Look for the NDC code 66758-235-31 with lot number VA0099422 and expiration date June 30, 2028.
Check the label for the correct lot number and expiration date. If missing or incorrect, contact Sandoz for further instructions.
We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.
Subject: Recall D-0608-2026 — Sandoz Sandoz Hello, I own a Sandoz that is covered by recall D-0608-2026 from Sandoz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
