Gatorade Recalls 122,000 Cases of Sports Drinks Over Fears of 'Adverse Health Consequences'

PepsiCo is recalling 122,021 cases of Gatorade across 37 US states after discovering that some bottles contain artificial food colours that were not declared on their labels.

The recall affects only 28-ounce bottles of four varieties: Gatorade Lemon Lime, Lemon Lime Zero, Orange and Orange Zero. The affected products contain Yellow No. 5 and/or Yellow No. 6, according to the US Food and Drug Administration (FDA).

PepsiCo voluntarily initiated the recall on 25 September. The FDA classified it as a Class II recall on 2 October, and the action remains ongoing under recall number H-0009-2027.

The affected products were distributed across states including California, Texas, Florida, New York, Pennsylvania, Illinois, Michigan, Ohio, New Jersey and Washington. The full distribution list covers 37 states.

The recalled bottles carry 15 affected lot codes, with best-by dates ranging from 18 April 2027 to 8 June 2027. Consumers are being urged to compare the lot information on their bottles with the FDA's recall listing before drinking the products.

The FDA's latest enforcement information does not indicate that the recall was prompted by a confirmed outbreak or widespread illness. Instead, it concerns the failure to declare the colours on the product labels.

FDA Says Serious Risk Is Remote

The FDA's Class II classification means the products could cause 'temporary or medically reversible adverse health consequences', or that the probability of serious adverse health consequences is considered remote.

Both Yellow No. 5, also known as tartrazine, and Yellow No. 6, known as Sunset Yellow FCF, are permitted colour additives in the US. However, federal labelling rules require their presence to be declared.

Yellow No. 5 has received particular attention because the FDA says it 'may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons'. Such reactions are considered uncommon, meaning the recall does not suggest that Gatorade is generally dangerous for the wider population.

The recall is therefore primarily a labelling compliance issue involving a potential sensitivity risk, rather than evidence that the beverages have caused a broad public health incident.

The FDA's recall system distinguishes Class II recalls from Class I actions, which involve a reasonable probability that use of a product could cause serious adverse health consequences or death.

Recall Comes Amid Gatorade Reformulation

The Gatorade recall comes as PepsiCo works to reduce artificial colours across its portfolio. The FDA says PepsiCo plans to remove FD&C colours from Gatorade Thirst Quencher and Gatorade Zero products, including fruit punch, lemon lime and orange varieties, in autumn 2026.

That broader reformulation effort makes the current recall particularly notable because the affected drinks contain colours that were not properly declared, even though the additives themselves remain approved for use.

As of the latest update, consumers who have one of the affected 28-ounce bottles should check the lot code and best-by date against the FDA's list rather than relying solely on the flavour or bottle size.

PepsiCo has not publicly indicated that the recall involves all Gatorade products, and the FDA listing remains limited to the specified flavours, sizes and lot codes.

The agency continues to list the recall as ongoing. Consumers with matching products should avoid drinking them and follow PepsiCo or retailer instructions regarding the recalled items