From the U.S. Food and Drug Administration (FDA).
Cronobacter and Salmonella
The FDA warns that powdered infant formula can carry Cronobacter and Salmonella, which can cause serious illness in infants. Follow safe preparation and storage instructions, and discard recalled lots.
Switching formula? Check with your pediatrician first
Signs a formula may not agree with a baby — such as changes in stool, gas, or fussiness — can have many causes. Talk to your pediatrician before switching, especially for specialized or hypoallergenic formula. TinySafe does not give medical advice; it tracks recalls.
Check the lot number and date
Formula recalls usually apply to specific lot numbers and expiration dates printed on the container. Match yours against the official FDA record before using or discarding.
53 recalls grouped by reason. Each links to its official recall record.
Common questions
My baby's formula doesn't seem to agree with them — what should I do?
Symptoms like changes in stool color, gas, or fussiness can have many causes, so talk to your pediatrician about whether and how to switch formula. TinySafe doesn't give medical advice — but if you do switch, you can check here that the new formula hasn't been recalled.
Which sensitive or hypoallergenic formulas have been recalled?
Several gentle, sensitive, and hypoallergenic formulas have been recalled, including products like Enfamil Nutramigen, Gerber Good Start SoothePro, and Similac Sensitive — often for bacteria. The full list grouped by type, with official FDA sources, is on this page.
Which baby formula brands have been recalled?
TinySafe tracks FDA infant formula recalls across major brands, including Similac (Abbott), Enfamil, ByHeart, Gerber Good Start, and store brands. The full list grouped by brand, with official FDA sources, is on this page.
Is ByHeart formula safe? Was Similac or Enfamil recalled?
ByHeart has been recalled more than once, including for bacteria and botulism risk. Abbott (Similac) and Mead Johnson (Enfamil) products also appear in FDA recalls. Check the specific product and lot number on this page against the official FDA source.
Are European formulas like HiPP and Holle FDA-regulated?
European formulas such as HiPP and Holle are not reviewed by the FDA the same way U.S. formulas are, and some have appeared in U.S. recalls or import alerts. Check specific products against official recalls, and talk to your pediatrician before using imported formula.
Is there lead or heavy metals in baby formula?
Independent testing (such as Consumer Reports) has reported trace heavy metals in some formulas. Trace amounts are common because metals occur naturally in soil and water; a recall is different — it means a specific product exceeded a limit. TinySafe lists formulas formally recalled; for general heavy-metal concerns, the FDA's Closer to Zero initiative and your pediatrician are the right sources. We report recalls, not test rankings.
What's the 'best' or 'safest' baby formula?
There isn't one. U.S. infant formula is heavily regulated, and pediatricians generally say the best formula is the one your baby tolerates, that you can reliably get and afford. TinySafe can't tell you which to pick — we have no review data and don't rank brands. What we can do is show you, objectively, which brands have a recall history and why, so that's one factor you can weigh. For choosing a formula, ask your pediatrician.
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.