Baby and kids' product recalls

Potential for the product to develop mold and spoil.

Infant formula contains undeclared tyrosine

The baby monitor's battery can malfunction, overheat and burst, posing a fire hazard.

The recalled helmets do not comply with the positional stability requirements of the U.S. CPSC federal safety standard for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.

When using the recalled bath toys, particularly in a bathtub or wading pool, a child can slip and fall or sit onto the hard plastic top fin of the shark, posing risks of impalement, lacerations and punctures.

The ceramic mugs are mislabeled as microwave safe. If microwaved, the metallic print on the mug can spark, posing a fire hazard.

The recalled dietary supplements contain iron which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.

IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment

There have been reports of skin burns to children wearing the device.

Label declares bovine colostrum but does not declare milk allergen.

Label declares bovine colostrum but does not declare milk allergen.

Label declares bovine colostrum but does not declare milk allergen.

The recalled children's pajamas and nightdresses fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The recalled children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The bath seats fail to meet the federal safety standard for infant bath seats, including requirements for stability and leg openings, and can tip over while in use, posing a drowning hazard to babies.

Import Violation

The rear wheel can loosen or fall off the scooter, posing a fall hazard to children.

Produced Without Benefit of Inspection

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

The paint on the recalled electric bikes contains levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard. Lead is toxic if ingested by young children and can cause adverse health issues.

The paint on the recalled electric bikes contains levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard. Lead is toxic if ingested by young children and can cause adverse health issues.

The activity table contains a silver metal bell which can detach from its metal arch, posing a choking hazard to young children.

The recalled products contain diphenhydramine hydrochloride and acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

Label lists squid; contains statement lists Fish(squid); other fish not listed in ingredients or contains statement

Colostrum is declared but label does not declare milk.

Potential undeclared allergen from cross contamination. Product contains tree nuts (hazelnuts and walnuts) and potential cross contamination from other tree nuts (almonds and cashews).

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications