Quality issue
Medications
FDA
Is the Infants Simethicone Drops, Active ingredient (in each safe?
Vintage Pharmaceuticals, Llc · Recalled Apr 20, 2010
No — the Infants Simethicone Drops, Active ingredient (in each was recalled on Apr 20, 2010 due to a potency/quality issue. May be weaker than labeled, so it may not work as expected. If you have this product: This product may not work as intended (it may be weaker or stronger than labeled). Stop using it and replace it with an unaffected product. Ask your pharmacist or pediatrician if you have dosing concerns.
Why it was recalled
May be weaker than labeled, so it may not work as expected.
What to do
This product may not work as intended (it may be weaker or stronger than labeled). Stop using it and replace it with an unaffected product. Ask your pharmacist or pediatrician if you have dosing concerns.
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.
Infants Simethicone Drops, Active ingredient (in each: common questions
Is the Infants Simethicone Drops, Active ingredient (in each safe?
No. The Infants Simethicone Drops, Active ingredient (in each was recalled on Apr 20, 2010 due to a potency/quality issue. May be weaker than labeled, so it may not work as expected.
Has the Infants Simethicone Drops, Active ingredient (in each been recalled?
Yes. The Infants Simethicone Drops, Active ingredient (in each was recalled on Apr 20, 2010. The recall was issued by FDA (recall ID D-613-2010).
Why was the Infants Simethicone Drops, Active ingredient (in each recalled?
May be weaker than labeled, so it may not work as expected.
What should I do if I have the Infants Simethicone Drops, Active ingredient (in each?
This product may not work as intended (it may be weaker or stronger than labeled). Stop using it and replace it with an unaffected product. Ask your pharmacist or pediatrician if you have dosing concerns.
Where can I find the official recall notice for the Infants Simethicone Drops, Active ingredient (in each?
The official FDA recall record is available
here. Always verify recall details with the official source.
TinySafe is an independent app and is not affiliated with, endorsed by, or sponsored by the FDA or CPSC. Always confirm recall details with the official source. The absence of a recall does not guarantee a product is safe.
