Baby and kids' product recalls

Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.

Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

Labeling: Missing label: the product tube was missing a label and contained a different formulation.

The markings on the outside of the bottles contain levels of lead that exceeds the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.

The fabric playhouses and play tents fail to meet an industry flammability standard for these products, posing a risk of burn injuries to children.

The recalled products contain low-viscosity hydrocarbons 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. In addition, the label on the products violates the Federal Hazardous Substances Act (FHSA) by omitting the mandatory information on the packaging.

A small dowel can become exposed and detach from the toy box, posing a choking hazard to young children.

The mirror can come out of the silicone bear cover if pushed, exposing sharp edges of the mirror, posing a laceration hazard to children.

Elevated levels of thallium (heavy metal)

Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.

The pom poms on the book can detach, posing a choking hazard to young children.

Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.

The product contains lidocaine which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child resistant, posing a risk of poisoning to young children if they ingest the anesthetic cream.

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

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

Improper insertion of the pins provided for assembly can cause the chair's legs to collapse, posing an injury hazard to the user.

The microbial test result is found to be out of specification due to high yeast and mold counts.

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

The metal snaps on the rompers can detach, posing a choking hazard to young children.

The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.

The xylophone's feet can loosen and fall off, posing a choking hazard to young children.

Surface paint on the desks and chairs contains levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard. The desks and chairs also fail to comply with the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.

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

The recalled over-the-counter product contains the regulated substance 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.

The chairs can tip over or collapse when a consumer is seated in the chair, posing a fall hazard.

The recalled over-the-counter product contains the regulated substance acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

The recalled over-the-counter products contain the regulated substance 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.

The recalled over-the-counter products contain the regulated substances aspirin and ibuprofen 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.

Foreign material (metal). Products contain bacon that is being recalled by Smithfield due to the presence of metal in the bacon.