Similac Class Action Lawsuit Claims Certain Infant Formulas Contain Heavy Metals

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A proposed class action lawsuit accuses Abbott Laboratories of failing to warn consumers that some of its Similac powdered infant formulas contain harmful levels of arsenic, cadmium, lead and mercury.

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According to the 85-page lawsuit, the manufacturer has intentionally concealed that certain Similac products contain or risk containing heavy metals, which are known to pose health risks to humans—particularly infants and toddlers. The suit alleges the company has misled consumers into believing the items are safe and made with high-quality, nutritious ingredients because their packaging and marketing materials contain no warning about the potential presence of harmful substances.

As the case tells it, recent testing revealed the presence of heavy metals in the following Similac infant formula products:

• Similac Pro-Advance;
• Similac 360 Total Care;
• Similac Soy Isomil;
• Similac Advance OptiGRO Powder, Milk-Based;
• Similac NeoSure; and
• Similac Total Comfort.

“Testing from 2022 and 2023, which includes [Abbott Laboratories’] own testing as well as [the plaintiffs’] testing, shows that at least one heavy metal was present in all but two of the 121 samples tested, meaning only 1.65% had non-detectable levels of any Heavy Metals,” the class action suit relays.

Although no maximum allowable level has been established for these heavy metals in infant formulas, the U.S. Food and Drug Administration has set the maximum contaminant level for arsenic and cadmium in bottled water at 10 and five parts per billion (ppb), respectively, the complaint says.

In spite of this, laboratory tests indicated that certain Similac products contained arsenic levels as high as 59.3 ppb and cadmium levels as high as 11.4 ppb, the filing contends.

In addition, testing indicated that some of the infant formulas contained up to 3.6 ppb of lead, an “extremely toxic” substance whose harms “cannot be reversed or remediated,” the Similac lawsuit claims.

Per the suit, the analysis also showed that certain products contained mercury levels as high as 10.1 ppb, even though the U.S. Environmental Protection Agency has set a maximum allowable level for the substance in drinking water at two ppb.

It has been well established by government agencies and medical experts that there are “no known safe levels of heavy metals,” the case charges. According to the complaint, infants and toddlers are particularly vulnerable to the toxic effects of these substances because of their small size and developing brains and nervous systems. Even when trace amounts are found in food products such as Similac infant formulas, the heavy metals can cause serious damage to brain development because they accumulate in the body over time, the filing asserts.

The lawsuit claims the manufacturer has “knowingly chose[n]” not to disclose to consumers that its infant formulas potentially contain arsenic, cadmium, lead or mercury, despite the recognized health risks to babies and toddlers.

“Based on the messaging and overall impression communicated by the packaging and the material nondisclosures, no reasonable consumer could expect or understand that the Infant Formulas contained or risked containing Heavy Metals, especially in these circumstances because the developmental and physical risks created by ingestion of Heavy Metals by infants are well recognized,” the case argues.

The complaint alleges that reasonable consumers would not have purchased the Similac products at issue had they known the items potentially contained substances hazardous to their child’s health.

The lawsuit looks to represent all individuals who, since March 7, 2019, purchased the infant formulas listed on this page for household use and not for resale.

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