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Quality issue Medications FDA

Is the Simethicone, Infants safe?

Advantage Dose LLC · Recalled Nov 26, 2008
No — the Simethicone, Infants was recalled on Nov 26, 2008 due to a quality issue. Was made outside required quality standards, which can mean a hidden contamination or safety risk. If you have this product: Stop using this product. It was made outside required quality standards, which can mean a contamination or safety risk. Return it for a refund.
Why it was recalled
Was made outside required quality standards, which can mean a hidden contamination or safety risk.
What to do
Stop using this product. It was made outside required quality standards, which can mean a contamination or safety risk. Return it for a refund.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.

Simethicone, Infants: common questions

Is the Simethicone, Infants safe?
No. The Simethicone, Infants was recalled on Nov 26, 2008 due to a quality issue. Was made outside required quality standards, which can mean a hidden contamination or safety risk.
Has the Simethicone, Infants been recalled?
Yes. The Simethicone, Infants was recalled on Nov 26, 2008. The recall was issued by FDA (recall ID D-1474-2009).
Why was the Simethicone, Infants recalled?
Was made outside required quality standards, which can mean a hidden contamination or safety risk.
What should I do if I have the Simethicone, Infants?
Stop using this product. It was made outside required quality standards, which can mean a contamination or safety risk. Return it for a refund.
Where can I find the official recall notice for the Simethicone, Infants?
The official FDA recall record is available here. Always verify recall details with the official source.
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