Gatorade Recall: 122,021 Cases Had Undeclared Yellow Dyes

On September 25, 2026, PepsiCo initiated a voluntary recall of 122,021 cases of 28 oz Gatorade Lemon Lime, Orange, and their Zero varieties across 37 states due to undeclared FD&C Yellow No. 5 and/or Yellow No. 6. The U.S. Food and Drug Administration (FDA) classified the action as a Class II recall on October 2, 2026. This classification indicates that exposure to the violative product may cause temporary or medically reversible adverse health consequences, though the probability of serious harm remains remote.

Key takeaways:

• The recall covers 122,021 cases of 28 oz Gatorade bottles across four flavors: Lemon Lime, Lemon Lime Zero, Orange, and Orange Zero.
• The FDA Enforcement Report lists 15 lot codes, with dates in the codes running from APR 18 27 to JUN 08 27, and distribution to 37 states.
• FDA classified the recall as Class II. The stated reason is undeclared Yellow No. 6 and/or Yellow No. 5, and FDA does not say which flavor contained which dye.
• Federal labeling rules mandate specific ingredient naming for certified color additives on packaged food and beverage labels.

What happened

PepsiCo Inc., headquartered in Purchase, New York, initiated a firm-directed voluntary recall on September 25, 2026, targeting 122,021 cases of 28-ounce sports drinks. The products involved cover four specific beverage varieties: Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero. The FDA record lists the firm's initial notification of consignees as "Visit."

The FDA formally classified the ongoing event as a Class II recall on October 2, 2026, under Recall Number H-0009-2027 and Event ID 99991. The official FDA Enforcement Report gives the reason for the recall, verbatim, as "Undeclared Yellow No. 6 and/or Yellow No. 5." The record also states "Press Release Not Issued For This Recall." TODAY.com reported on October 5, 2026, that it had reached out to PepsiCo for comment but had not heard back by publication.

The FDA record lists the recall's status as ongoing and describes it as "Voluntary: Firm initiated," meaning PepsiCo started the recall a week before FDA classified it.

What changed

The enforcement action centers strictly on missing ingredient declarations rather than physical adulteration or contamination. Under federal regulatory definitions, the beverages represent violative product because certified color additives were present in the liquid without matching declarations on the packaging labels.

According to FDA's recall definitions, a Class II recall occurs when exposure to a violative item may lead to temporary or medically reversible adverse health consequences, or where the risk of severe health outcomes is remote. The FDA Enforcement Report notes that this remains an ongoing voluntary recall. For how US and EU dye rules differ, see EU Warning-Label Additives Still Allowed in the US.

What the record does not say is how the dyes came to be undeclared. A label error, a formula change and a wrong label on the bottle are all possible; FDA's report does not specify, and PepsiCo has not commented publicly.

Who is affected

The recall encompasses 122,021 cases distributed across 37 states. The geographic distribution pattern includes: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, and WI. Specific retailers receiving these shipments were not identified in the public regulatory filing.

The enforcement record identifies 15 specific production lots, all packaged in 28 oz containers. The verbatim code information provided by the FDA includes:

• Lot 091026 DL - JUN 07 27
• Lot 091126 DL - JUN 08 27
• Lot 072226 DT - APR 18 27
• Lot 072426 TL - APR 20 27
• Lot 073126 TL - APR 27 27
• Lot 072926 TL - APR 25 27
• Lot 073026 TL - APR 25 27
• Lot 081026 TL - MAY 07 27
• Lot 082126 OA - APR 18 27
• Lot 080126 DL - APR 28 27
• Lot 082026 DL - MAY 17 27
• Lot 083126 DT - JUN 07 27
• Lot 082526 KM - MAY 22 27
• Lot 090426 KM - JUN 01 27
• Lot 072726 TL - APR 23 27

The FDA documentation combines all four flavors under a single product entry and does not match individual lot codes to specific flavors. Furthermore, the records do not indicate whether other container sizes or multi-packs are implicated in the action.

What it means for shoppers

For shoppers holding 28 oz bottles of Gatorade Lemon Lime, Orange, or their Zero counterparts in the 37 listed states, comparing the lot code printed on the bottle with the 15 codes above is the way to check whether it is part of the recall. The FDA record does not say where on the bottle the code is printed.

Consumers tracking specific food colors can review educational resources such as what is tartrazine (yellow 5) and guides addressing whether yellow 6 is safe. For those monitoring ingredients closely, the omission removes the transparency required by federal labeling mandates.

It is important to state clearly what the current evidence cannot establish: the public FDA records do not disclose whether any adverse reactions or illnesses have been reported, nor do they determine whether the omission stemmed from packaging mislabeling or formulation errors.

Refund or return instructions have not been published, and the FDA record lists no consumer hotline.

The background

Under 21 CFR 101.22(k), "The label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients." Specifically, any color additive certified under Section 721(c) of the Federal Food, Drug, and Cosmetic Act must be listed by its specific certified name rather than generic terminology like artificial color.

FD&C Yellow No. 5 has an extra rule under 21 CFR 74.705(d)(2). This regulation dictates that any food for human use containing FD&C Yellow No. 5 must declare its presence explicitly on the label by its certified name in the ingredient statement.

FDA's color additives Q&A for consumers puts it simply: "The label must list the names of any FDA-certified color additive (e.g., FD&C Blue No. 1 or the abbreviated name, Blue 1)." The same page lists beverages among the common uses of both FD&C Yellow No. 5 and FD&C Yellow No. 6.

What to watch next

The FDA record lists the recall as ongoing. Several basics are still unknown: which of the four flavors contained Yellow 5, Yellow 6 or both, which lot belongs to which flavor, how the dyes came to be left off the label, and which retailers received the bottles.

Watch for a PepsiCo statement or retailer notices with refund or return instructions, since none have been published. People who avoid Yellow 5 or Yellow 6 can check the lot code before drinking a 28 oz bottle of these flavors.

Any change to the recall's status will show on the FDA Enforcement Report event page.