Sandoz Pediatric Infuvite Vials Recall: Defective Container Risk
Sandoz recalls pediatric Infuvite vitamin kits due to sub-optimal vial crimping. This may cause leaks or contamination. Affected kits have NDC 54643-5647-0, lot JX907, expiring 02/2021.
Lower-risk recall
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
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What happened, in plain English
Sandoz recalled pediatric Infuvite vitamin kits because the vials have sub-optimal crimping, which could lead to leaks or contamination. This affects children's medication safety. Read more at govinfonow.com/recall/37134-sandoz-pediatric-infuvite-vials-recall-defective-container-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37134-sandoz-pediatric-infuvite-vials-recall-defective-container-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1259-2020
Cite this page
“Sandoz Pediatric Infuvite Vials Recall: Defective Container Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37134-sandoz-pediatric-infuvite-vials-recall-defective-container-risk. Based on FDA recall #D-1259-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1259-2020%22&limit=1).
Why it’s dangerous
The vials have sub-optimal crimping, meaning the seals might not close properly. This could allow liquid to leak or contaminate the product, posing a risk of improper medication intake.
Who’s affected
Parents or caregivers of children using the recalled Infuvite pediatric vitamin kits. Children receiving these vitamins are at risk of contamination or leaks.
How to tell if you have this one
Check for the NDC code 54643-5647-0 on the kit. The lot number JX907 and expiration date 02/2021 are also specific identifiers for this recall.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Vial Seals
Inspect the vials for signs of poor crimping, such as leaks or improper sealing.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1259-2020 (April 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1259-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.