Baby and kids' product recalls

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: product held outside appropriate storage temperature conditions.

CGMP Deviations: product held outside appropriate storage temperature conditions.

The ride-on toy can tip forward when a young child is riding it, posing fall and injury hazards to children.

The brass water tap of the play kitchen contains levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.

When attached to a crib, a protruding knob on the activity desks can become entangled with clothing on a child, posing an entanglement hazard. The opening in the handle on the desks can also pose a jaw entrapment hazard to children under 18 months.

Detectable levels of Per- and polyfluoroalkyl substances (PFAS).

Product Contamination

The children's sweatshirts have a drawstring in the hood that can become entangled or caught on objects, posing a strangulation hazard to children.

CGMP Deviations: products were stored outside the drug label specifications.

CGMP Deviations: products were stored outside the drug label specifications.

When the swing or rocker is not in use, their restraint straps can dangle below the seat and non-occupant crawling infants can become entangled in the straps, posing a strangulation hazard.

Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate if there is a hazardous gap and suffer serious injuries or death when the elevator is called to another floor.

Acidified/Low Acid dietary supplement with no approved process.

Acidified/Low Acid dietary supplement with no approved process.

Acidified/Low Acid dietary supplement with no approved process.

Two food trailers holding various types and brands of frozen foods were temperature abused during deliver to two retail stores.

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.