Gatorade Recall: PepsiCo Pulls 122,000 Cases in 37 States Over Undeclared Artificial Yellow Dyes, FDA Says

NEW YORK — PepsiCo has recalled more than 122,000 cases of Gatorade sold in 37 states because the sports drinks contain artificial yellow dyes that are not listed on their labels, according to the U.S. Food and Drug Administration.

The recall covers 122,021 cases of 28-ounce bottles of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange and Gatorade Orange Zero, the FDA said in its weekly enforcement report.

The agency said the drinks contain undeclared FD&C Yellow No. 5 and/or Yellow No. 6, synthetic food dyes that give foods and beverages a yellow or orange color. Federal rules require both dyes to be listed on product labels.

PepsiCo, which owns the Gatorade brand, voluntarily began the recall on Sept. 25. The FDA classified it on Oct. 2.

No illnesses or reactions linked to the recalled bottles had been reported as of Sunday, according to published reports. The FDA said no press release had been issued for the recall.

Class II designation

The FDA designated the action a Class II recall, the agency's middle tier of three risk categories.

The FDA defines a Class II recall as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

A Class I recall, the most serious category, involves a reasonable probability that a product will cause serious health problems or death. A Class III recall involves products unlikely to cause any adverse health consequences.

Which products are affected

The recall is limited to 28-ounce bottles of the four flavors. Other bottle sizes and flavors are not included, according to the FDA notice.

The affected bottles carry 15 specific lot codes, with best-by dates ranging from April to June 2027. Consumers can check the lot codes by searching for "Gatorade" in the FDA's online enforcement report database.

The drinks were distributed to 37 states, including California, Texas, Florida, New York, New Jersey, Pennsylvania, Illinois, Alaska, Kentucky, North Carolina and Utah.

Consumers who have the recalled bottles may return them to the place of purchase or discard them. People who have consumed the drinks and experience symptoms such as hives, swelling or difficulty breathing should seek medical attention.

Why the dyes matter

Yellow No. 5, also known as tartrazine, and Yellow No. 6, known as Sunset Yellow FCF, are among the most widely used artificial colorings in the United States. Both are approved by the FDA for use in food when used under specific conditions, including proper labeling.

Labeling requirements exist because a small number of people are sensitive to the dyes. Yellow No. 5 can cause allergic-type reactions, including hives and itching, in some individuals, according to the FDA. The agency says such reactions are uncommon in the general population but occur more frequently in people who are also sensitive to aspirin.

Some research has also linked the dyes to asthma symptoms in sensitive consumers. Health advocates have raised concerns about possible links between synthetic dyes and behavioral problems in some children, though regulators have said the evidence is not conclusive.

Because the recalled Gatorade did not list the dyes, consumers who avoid them for health reasons may have consumed them unknowingly.

Push against artificial dyes

The recall comes as artificial food dyes face growing scrutiny in the United States.

In April 2025, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced plans to phase out petroleum-based synthetic dyes from the nation's food supply, urging manufacturers to eliminate them by the end of 2026. The plan relies largely on voluntary commitments from food companies.

Several states have also passed laws restricting artificial dyes, particularly in school meals.

Major food and beverage companies, including PepsiCo, have pledged to reduce or remove artificial colors from their products. PepsiCo has said it plans to shift toward natural colorings across its portfolio, and the company has introduced versions of Gatorade made without artificial dyes.

It has not been confirmed whether the labeling error is connected to Gatorade's transition away from artificial colors. The FDA notice did not explain how the dyes came to be left off the labels.

PepsiCo did not immediately respond to a request for comment on the recall.

A leading sports drink

Gatorade is the best-selling sports drink in the United States and one of PepsiCo's most valuable brands. Created in 1965 at the University of Florida to help the school's football players stay hydrated, the drink was acquired by PepsiCo in 2001 through its purchase of Quaker Oats.

Lemon Lime is one of Gatorade's oldest and most popular flavors, along with Cool Blue and Fruit Punch. The Zero versions are sugar-free alternatives that have grown in popularity as consumers seek lower-calorie drinks.

The brand faces growing competition from newer hydration drinks, including Prime, BodyArmor and electrolyte powders, many of which market themselves as free of artificial dyes.

Recalls on the rise

The Gatorade action is one of several recent food and beverage recalls involving undeclared ingredients. Undeclared allergens and additives are among the most common reasons for food recalls in the United States.

Food safety experts say even recalls classified as lower risk are important because they protect consumers with allergies or sensitivities who rely on accurate labels to make safe choices.

The FDA's enforcement report listed the Gatorade recall as ongoing.

Consumers with questions about the recall can contact PepsiCo's consumer relations line, listed on Gatorade packaging, or check the FDA's website for updates.