The U.S. Food and Drug Administration has issued a nationwide recall that touches more than 122,000 cases of Gatorade, a product line owned by PepsiCo. The recall spans 37 states, including high-volume markets such as New York, New Jersey, Pennsylvania, Florida, Texas and North Carolina. All affected items are 28-ounce bottles of the Lemon Lime, Lemon Lime Zero, Orange and Orange Zero varieties. The agency’s notice indicates that the bottles may contain undeclared food dyes specifically Yellow No. 5, Yellow No. 6, or both.
PepsiCo initiated the voluntary recall on September 25, and the FDA classified it as a Class II recall on October 2. A Class II designation means that consumption of the product could lead to temporary or medically reversible health effects, while the chance of severe outcomes is considered remote. The recall remains active, and the FDA’s enforcement report lists the precise lot numbers that consumers should examine.
Recall scope and affected flavors
The recall covers 122,021 cases of four specific flavors, each sold in 28-ounce bottles. The flavors — Lemon Lime, Lemon Lime Zero, Orange and Orange Zero — are among Gatorade’s most popular options, often stocked in gyms, convenience stores and supermarkets. Distribution records show that the affected shipments reached retailers across the 37-state footprint, with New York and New Jersey highlighted as key markets. The breadth of the recall underscores how a labeling oversight can quickly become a national consumer-safety issue.
Because the issue centres on undisclosed color additives, the recall does not involve a defect in the drink’s taste or nutritional content. Instead, the problem lies in the labeling: the presence of Yellow No. 5 and/or Yellow No. 6 was not indicated on the ingredient list. This omission is critical for individuals who are sensitive to synthetic dyes, as reactions can range from mild skin irritation to more pronounced allergic responses.
FDA classification and health implications
A Class II recall signals that exposure to the product may cause temporary or medically reversible adverse health effects. In the context of food dyes, the most common concerns involve allergic reactions, hives, or gastrointestinal discomfort in dye-sensitive consumers. The FDA’s assessment notes that the probability of serious health consequences is remote, meaning that the majority of the public is unlikely to experience lasting harm.
Nevertheless, the agency urges anyone who suspects they have consumed a recalled bottle to monitor for symptoms and seek medical advice if necessary. Because the dyes in question are synthetic, the risk is largely confined to individuals with pre-existing sensitivities. For the general population, the primary risk is a breach of trust in product labeling rather than a direct health threat.
How consumers can verify their bottles
Consumers should locate the lot number on the bottle’s neck or base and compare it against the list published in the FDA’s recall notice. The notice specifies the exact range of lot codes tied to the contaminated batches. If a bottle’s lot number falls within that range, the product should be set aside and returned to the point of purchase for a refund or replacement, although the recall announcement did not detail refund policies.
Retailers are expected to remove the affected inventory from shelves promptly. Shoppers who have already purchased the drink are encouraged to keep the receipt, retain the bottle, and contact the store where it was bought for guidance. Staying informed through the FDA’s website or contacting the agency directly can provide the most up-to-date information on the recall’s progress.
