‘Insufficient’ ByHeart Recall of Contaminated Infant Formula Benefits Very Few Consumers, Class Action Alleges

A proposed class action lawsuit alleges that ByHeart’s voluntary recall of its “mislabeled” infant formula products contaminated with the Clostridium botulinum bacterium was woefully insufficient and deliberately designed to minimize the manufacturer’s liability.

The 21-page ByHeart lawsuit contends that the defendant “improperly, deceptively, and misleadingly” labeled and advertised the Whole Nutrition infant formula at issue by failing to disclose on product packaging that the formula was contaminated with a bacteria that can lead to infant botulism, a rare illness that can be life-threatening to babies.

According to the class action lawsuit, ByHeart’s November 2025 voluntary recall of the contaminated infant formula was wholly inadequate, as the initiative included refunds for only certain affected consumers, who were instructed to throw away the ByHeart products, and was seemingly designed to shift liability away from the company.

Per the complaint, ByHeart has a responsibility to provide consumers with accurate information about its products and possesses “superior knowledge” about the formula manufacturing process. The suit says that ByHeart’s failure to disclose on product packaging that the Whole Nutrition formula may be contaminated with infant botulism was likely to deceive reasonable consumers, who rely on the information on product labels when making purchasing decisions.

“Plaintiffs and other Class Members have been injured because they purchased Products that were mislabeled, unhealthy, and entirely worthless,” the case summarizes.

Clostridium botulinum is a harmful bacterium that can lead to life-threatening health consequences for infants, whose digestive tracts and immune systems are not fully developed, the lawsuit explains. Some symptoms of infant botulism include constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, respiratory difficulty and generalized weakness, the filing relays.

According to the complaint, the presence of infant botulism-causing bacteria in the ByHeart formula was confirmed on November 8 after preliminary testing was conducted by the California Department of Public Health. On November 14, the Food and Drug Administration and Centers for Disease Control and Prevention stated that 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart’s Whole Nutrition formula have been reported from 13 states.

ByHeart lawsuit argues that recall was insufficient, too limited

On November 8, ByHeart announced that, “out of an abundance of caution,” it had voluntarily recalled two batches of its Whole Nutrition infant formula. The recall came in the wake of a notification from the FDA concerning a broader, ongoing inquiry into an outbreak of infant botulism, the announcement stated. Per the case, a complete product recall was rolled out on November 11.

The lawsuit charges, however, that ByHeart designed the recall to “shift responsibility onto retailers,” who had no hand in making, marketing or distributing the contaminated infant formula. The case highlights that ByHeart was “well aware” that any consumer who heard of the infant formula recall would be inclined to throw the impacted products away, and that consumers may shop at different locations and not buy the formula at the same store each time.

Moreover, the filing says that most consumers do not maintain receipts and, as a result, cannot obtain a formula refund at the point of purchase.

ByHeart stated online that orders placed on the company’s website on or after October 1 of this year will be eligible for a refund, though only for up to two units. The lawsuit spotlights that a consumer looking for an infant formula refund would need to “dig into the recall FAQs” to learn that they need to contact the retailer from whom they bought the product, such as Amazon, for help with their refund options.

“Accordingly, Defendant’s recall is designed to minimize Defenant’s own liability, to reach very few people, and to benefit very few of the consumers who purchased the Products,” the case alleges, arguing that a class action lawsuit is “superior to [ByHeart’s] failed recall in every conceivable fashion.”

ByHeart’s failure to disclose the contamination harmed consumers, case says

Because consumers cannot reasonably test or verify whether a product contains harmful substances or bacteria on their own, they must trust brands like ByHeart, which are subject to robust, comprehensive industry testing standards, the suit says.

The case adds that consumers also rely heavily on packaging and marketing when making purchasing decisions, and the lack of disclosure on ByHeart’s products about contamination risk was misleading and deceptive to consumers who believed they were buying a safe product.

“Had Defendant not made the false, misleading, and deceptive representations and omissions, Plaintiffs and the Class Members would not have been willing to pay the same amount for the Products they purchased and/or Plaintiffs and the Class Members would not have been willing to purchase the Products,” the case explains, stressing that consumers “did not obtain the full value of the advertised Product” due to the infant botulism contamination.

According to the suit, the FDA first sent a warning letter to ByHeart over alleged violations of infant formula manufacturing regulations in August 2023.

Who is covered by the ByHeart recall lawsuit?

The ByHeart recall lawsuit looks to represent all consumers who purchased the recalled ByHeart infant formula products anywhere in the United States during the applicable statute of limitations period.

How can I sign up for the ByHeart lawsuit?

Typically, there’s nothing you need to do to join or sign up for a class action lawsuit when it is initially filed. It is usually only in the event of a class action settlement that the people covered by the case, called class members, need to act. This can involve filling out and filing a settlement claim form online or by mail. In the event of a settlement, class members may receive a notice outlining the deal, their legal rights and potential options moving forward.

If you bought ByHeart Whole Nutrition Infant Formula that was recalled, attorneys working with ClassAction.org would like to hear from you. Read about our lawsuit investigation into the ByHeart infant botulism recall.

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