Cookie Recall Update For 15 States as FDA Issues Risk Level

Newsweek

2 days ago

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources.
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A food recall of nearly 6,000 cases of cookies distributed across 15 states has been given the U.S. Food and Drug Administration's (FDA) second-highest risk level.
Carley's Inc. voluntarily recalled 5,826 cases of its Soft Baked Iced Lemon Cookies, which contained a misbranded yellow color additive, which was incorrectly labeled "Artificial Yellow Color" instead of the regulatory "FD&C Yellow #5" (or Tartrazine), the FDA said.
The agency on Wednesday classified the recall a Class II, reserved for situations in which a product may cause temporary or medically reversible adverse health issues or there is a remote probability of serious adverse health consequences.
The cookies were shipped to wholesalers in the following states: Illinois, Michigan, Iowa, Louisiana, Maryland, Pennsylvania, Virginia, Minnesota, Alabama, Texas, Georgia, South Carolina, New York, North Carolina, and West Virginia.
Newsweek contacted Carley's via its information email on Thursday.
What To Know
The recalled product, Carley's Soft Baked Iced Lemon Cookies (5.34oz plastic tray), bears UPC code 7 40235 50011 0 and various lot codes including 01726-040225, 11245-012825, 031026-051425, 061925-082324, 080525-100924, 081725-102124, 091025-111424, and 112425-012825. Carley's shipped 5,826 cases (nearly 70,000 units) to wholesalers who then distributed them to retail stores in 15 states.
The recall was initiated on June 6. Carley's Inc. notified its customers and wholesalers using a combination of email, fax, letter, press release, telephone, and personal visits. No initial press release was formally issued for this recall.
Stock photo shows homemade cookies.
Stock photo shows homemade cookies.
Getty Images
The FDA requires specific identification of food color additives due to potential sensitivities. FD&C Yellow #5 (also known as tartrazine) has been associated with rare allergic-type reactions, particularly among individuals with aspirin sensitivity.
FD&C Yellow No. 5 is approved by the U.S. Food and Drug Administration (FDA) for use in foods, drugs, and cosmetics. It must be listed on ingredient labels because some people may have allergic reactions or sensitivities.
No U.S. state outright bans FD&C Yellow No. 5, but there have been increasing regulatory and labeling efforts around artificial food dyes, particularly in states like California and New York.
The FDA's Recall Levels Explained
Recalls are classified into a numerical designation (I, II, or III) by the FDA to indicate the relative degree of health hazard presented. The categories are:
Class I - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
What Happens Next
The voluntary recall remains ongoing.
The recall will remain active until the FDA and Carley's Inc. have resolved the labeling issue and ensured that all misbranded products are removed from the market. Consumers who have purchased affected cookies should return them for a full refund, and can monitor the FDA recall database for updates.