The U.S. Food and Drug Administration has classified PepsiCo's recall of Gatorade as a Class II risk, covering 122,021 cases of 28-ounce bottles sold across 37 states. The drinks contain undeclared FD&C Yellow No. 6 and/or Yellow No. 5 food dyes that were left off the ingredient labels. PepsiCo voluntarily initiated the recall on Sept. 25, and the FDA assigned the risk level on Oct. 2.
The recall covers 28-ounce bottles of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero, according to the FDA's enforcement report. The problem is a labeling failure: the bottles contained FD&C Yellow No. 5 (tartrazine) and/or Yellow No. 6 (Sunset Yellow FCF) that were not declared on the label.
The affected products were distributed in 37 states, including Alaska, Alabama, California, Florida, New York, Ohio, Pennsylvania, Texas, and Wisconsin. Consumers can check lot codes printed on the bottles: 15 lots are listed, with expiration dates ranging from April 18, 2027 to June 8, 2027.
PepsiCo began the recall voluntarily on Sept. 25. On Oct. 2, the FDA classified it as Class II, its second-highest risk tier, meaning use of or exposure to the product "may cause temporary or medically reversible adverse health consequences" or that the chance of serious harm is remote.
For most households, this is a labeling problem rather than contamination. Both dyes are FDA-approved food colors consumed daily by millions without issue. The risk falls on a smaller group: people who react to tartrazine, including some people with asthma or aspirin sensitivity who rely on ingredient labels to avoid it and may experience allergy-like reactions.
As of Oct. 4, no illnesses or reactions linked to the bottles had been publicly reported, and the FDA had not issued a separate public announcement. The recall details surfaced through the FDA's enforcement report, first flagged by Newsweek from FDA records, after which outlets including USA Today, Health.com, People, and WPIX followed up.
Consumers who keep Gatorade at home should match the lot code on their bottles against the FDA's list. If a bottle is among the recalled lots, stop drinking it and contact the retailer about a return. The FDA requires color additives to be approved and used within approved restrictions; an undeclared color makes the product violative.