U.S. — PepsiCo initiated a voluntary recall of 122,021 cases of Gatorade products in September 2024 due to undeclared Yellow No. 5 and Yellow No. 6 dyes. The recall affects approximately 122,021 cases of the sports drink distributed across 37 states.

The recalled products are 28-ounce bottles of Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero. These items contain undeclared Yellow No. 5 and/or Yellow No. 6 dyes, which were not listed on the product labels. The recall number is H-0009-2027.

The recalled products were distributed in 37 states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, and Wisconsin. Consumers can identify affected units by checking specific lot numbers and expiration dates printed on the bottles. The affected lot numbers and expiration dates are: Lot 091026 DL (June 7, 2027), Lot 091126 DL (June 8, 2027), Lot 072226 DT (April 18, 2027), Lot 072426 TL (April 20, 2027), Lot 073126 TL (April 27, 2027), Lot 072926 TL (April 25, 2027), Lot 073026 TL (April 25, 2027), Lot 081026 TL (May 7, 2027), Lot 082126 OA (April 18, 2027), Lot 080126 DL (April 28, 2027), Lot 082026 DL (May 17, 2027), Lot 083126 DT (June 7, 2027), Lot 082526 KM (May 22, 2027), Lot 090426 KM (June 1, 2027), and Lot 072726 TL (April 23, 2027).

A Class II recall means exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Yellow No. 5 may cause itching and hives in some people. 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.

What's New

PepsiCo previously faced a 2013 recall of Gatorade products due to the presence of brominated vegetable oil (BVO), a stabilizer later banned by the FDA in 2013. This marked the first major reformulation of Gatorade's ingredient list in response to regulatory pressure. The European Union has banned Yellow No. 5 and Yellow No. 6 in certain formulations, requiring warning labels for products containing these dyes. Countries including Austria, Norway, and Sweden prohibit their use in foods marketed to children, with strict labeling requirements for adult consumption.

The FDA's 2024 classification of this recall as a Class II event aligns with its 2019 guideline update, which clarified that Class II recalls apply to products with a low risk of serious harm, such as undeclared allergens or minor labeling errors. PepsiCo had previously announced in April 2026 that it would remove artificial colors from certain Gatorade flavors, including Lemon Lime and Orange, as part of a broader initiative to transition to natural colorants by 2027.

In April 2025, the U.S. Department of Health and Human Services announced plans to phase out six synthetic food dyes, including Yellow No. 5 and Yellow No. 6, by the end of 2026, citing potential health risks such as ADHD and obesity in children. The U.S. Department of Health and Human Services and FDA announced a phased removal of synthetic food dyes, including Yellow No. 5 and Yellow No. 6, from the food supply by 2027 due to potential health risks such as ADHD and obesity, particularly in children. In May 2025, the FDA approved natural food colorings as replacements for synthetic dyes, including Yellow No. 5 and Yellow No. 6, signaling a regulatory shift toward safer alternatives during growing consumer and industry pressure.

Why It Matters

Gatorade Orange Zero was first introduced in 2014 as a low-calorie, sugar-free alternative to traditional Gatorade Orange, and has since been part of the brand's core product line. The inclusion of this flavor in the recall shows the scope of the labeling error across both standard and zero-sugar variants of the beverage. The FDA's public enforcement report database indicates that this incident aligns with 12 other recalls involving undeclared allergens or labeling errors in 2024.

The regulatory environment surrounding synthetic dyes has shifted in recent years, with federal agencies moving toward phasing out these additives. The recall occurs against a backdrop of announced plans to remove Yellow No. 5 and Yellow No. 6 from the food supply due to cited health risks. This event reflects the ongoing tension between current labeling compliance and emerging regulatory standards for food colorants.