Major Gatorade Recall Affecting More Than 30 States Given Risk Warning - Newsweek

More than 122,000 cases of Gatorade sold across 37 states have been recalled after the U.S. Food and Drug Administration (FDA) warned that the drinks contained undeclared food colorings that could pose a risk to some consumers.

The FDA classified the recall as a Class II recall on October 2, covering 122,021 cases of 28-ounce bottles of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero. The products were recalled because they contain the unlisted food colorings, Yellow No. 5 and/or Yellow No. 6, according to the agency's enforcement report.

The recall was voluntarily initiated by PepsiCo on September 25 and remains ongoing. No public press release had been issued at the time of publishing.

Newsweek has contacted PepsiCo for comment.

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 chance of serious harm is considered to be unlikely.

Class II recalls are considered less severe than Class I recalls, which involve a “reasonable probability” of serious injury, illness, or even death, but they still indicate a potential health concern that warrants removing affected products from the marketplace.

Yellow No. 5, sometimes called tartrazine, and Yellow No. 6, known as Sunset Yellow FCF, are synthetic food dyes that are often used to give food and drinks a yellow or orange color.

Both Yellow No. 5 and Yellow No. 6 are approved for use by the FDA under specified conditions.

The issue in this recall isn’t that the dyes are banned, but that they weren’t declared on the product labels, potentially preventing consumers with sensitivities from avoiding them. The FDA specifically states that approved food colorings, including Yellow No. 5 and Yellow No. 6, are “required to be declared on product labels.”

Federal regulations specifically require warning statements for certain products containing Yellow No. 5 because the dye "may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons." The FDA notes that such sensitivity appears to be uncommon in the general population but is seen more frequently among people with aspirin hypersensitivity.

Research published in the National Library of Medicine has also linked synthetic food dyes, including Yellow No. 5 and Yellow No. 6, to hypersensitivity reactions such as hives and asthma symptoms in some people.

Consumers who have the recalled Gatorade products should check the bottle lot numbers against the recall notice and avoid consuming the affected products, particularly if they have known sensitivities to food dyes or a history of allergic reactions.

The recall remains active while PepsiCo and regulators continue monitoring the affected products.

Newsweek’s reporters and editors used Martyn, our AI assistant, to produce this story. Learn more about Martyn here. Contact Newsweek editors for this story: Tobias Meyjes and Anthony Murray.