Infant Formula Safety Under Fire as Contaminants Spark Legal Calls

PALM BEACH GARDENS, Fla. – January 09, 2026 – A recent wave of reports detailing bacterial and chemical contaminants in infant formula has ignited widespread concern among parents and drawn sharp calls for industry reform. Amidst growing public anxiety, legal experts are demanding that manufacturers take full responsibility for the safety of products that millions of families depend on.

Attorney Greg Yaffa, a shareholder at the Florida-based law firm Rafferty Domnick Cunningham & Yaffa, issued a forceful statement today, asserting that the burden of ensuring product safety must lie with corporations, not consumers. His comments come as families grapple with unsettling findings from both federal regulators and independent testing bodies.

“Infant formula is not a luxury product—it is a lifeline,” said Yaffa. “Families use it because they trust that manufacturers and regulators have done the hard work of ensuring these products meet the highest safety standards. When that trust is shaken, it creates fear and confusion where there should be reassurance.”

A Pattern of Contamination

The current concerns are not isolated incidents but part of a troubling pattern that has plagued the industry. In February 2022, Abbott Laboratories initiated a massive recall of its Similac, Alimentum, and EleCare formulas produced at its Sturgis, Michigan, plant due to potential contamination with Cronobacter sakazakii, a dangerous bacterium that can cause life-threatening infections like sepsis and meningitis in infants. The recall was linked to several infant hospitalizations and at least two deaths, although a direct genetic link was not established in the fatalities.

Subsequent investigations by the Food and Drug Administration (FDA) revealed unsanitary conditions and a history of contamination at the facility. This event triggered a nationwide formula shortage and intensified scrutiny of the entire industry. In August 2023, the FDA sent warning letters to three other major manufacturers—Mead Johnson Nutrition (maker of Enfamil), Perrigo Wisconsin, and ByHeart Inc.—citing the need to improve manufacturing processes to prevent bacterial contamination after each had conducted their own recalls for similar issues.

More recently, concerns have expanded beyond bacteria to include heavy metals and other toxins. A Florida state commission announced that its testing revealed elevated levels of heavy metals and pesticides in 16 popular infant formula brands. Notably, products like Similac Soy Isomil and Enfamil Prosobee were found to contain arsenic, cadmium, and lead, with some lead levels reportedly exceeding those considered safe for drinking water. Other studies have detected toxic plasticizers like DEHP and endocrine-disrupting chemicals in various formulas, raising alarms about the potential for long-term developmental and neurological harm.

Regulatory Gaps and Calls for Reform

Under current U.S. law, the FDA regulates infant formula under the Federal Food, Drug, and Cosmetic Act, which requires manufacturers to adhere to Good Manufacturing Practices (GMPs) and test for certain pathogens. However, the agency does not pre-approve formulas before they hit the market; instead, companies are required to notify the FDA of new products or significant changes. Critics argue this system is largely reactive, placing too much reliance on manufacturers to police themselves.

In response to these systemic vulnerabilities, bipartisan legislation has been introduced in Congress to strengthen federal oversight. The “Protect Infant Formula From Contamination Act,” reintroduced in February 2025, would mandate that companies test finished formula batches for Cronobacter and report any positive findings to the FDA within one business day—a significant change from current rules, which only require reporting if the contaminated product has already entered the market.

Another bill, the “Improving Newborns' Food and Nutrition Testing Safety Act” (INFANTS Act), aims to require testing for both toxic heavy metals and harmful bacteria, while also clarifying the FDA’s authority to issue mandatory recalls. These legislative efforts reflect a growing consensus that the existing framework is insufficient to protect the nation's most vulnerable population.

The Burden of Safety and Legal Accountability

In his statement, Yaffa emphasized that parents should not be expected to be chemists or toxicologists when choosing how to feed their children. His firm, which specializes in mass torts and corporate negligence, is positioning itself at the forefront of the fight for consumer protection in this arena.

“No parent should be put in the position of wondering whether the formula they can afford or access could harm their child over time,” Yaffa stated. “If testing reveals elevated levels of toxins, the responsibility lies squarely with the companies that produced those products to explain, correct, and prevent it from happening again.”

This sentiment underscores a potential shift toward significant legal challenges against formula manufacturers. The high concentration of the market, with a few key players like Abbott, Mead Johnson, and Nestlé dominating sales, makes these companies major targets for litigation when widespread safety failures occur. The firm’s track record in holding large institutions accountable suggests that statements like Yaffa’s are often a precursor to legal action aimed at securing justice for affected families and compelling systemic change.

The High Stakes for Infant Health

Pediatric health experts warn that the stakes could not be higher. Infants, particularly those who are premature or have weakened immune systems, are uniquely susceptible to the dangers of contaminated formula. Bacterial infections from Cronobacter or Salmonella can progress rapidly and be fatal. The chronic, low-level ingestion of heavy metals like lead and arsenic is linked to irreversible brain damage, lower IQ, and developmental delays.

Furthermore, the presence of endocrine disruptors such as phthalates and BPA in products designed for infants is deeply concerning, as these chemicals can interfere with hormonal systems critical for healthy growth and development. Yaffa stressed the need for a fundamental shift in the industry’s approach to safety.

“Safety cannot be reactive. It must be proactive, continuous, and verifiable,” he urged. “Infants are uniquely vulnerable, and the standards for products designed for them should reflect that reality every single day.”

As regulators, lawmakers, and legal advocates press for greater transparency and stricter standards, parents are urged to stay informed through credible sources and consult with their pediatricians. This moment serves as a critical wake-up call for an industry entrusted with the profound responsibility of nourishing the next generation, highlighting the urgent need to rebuild a system where safety is guaranteed, not just assumed.