Millions of consumers in the United States and in a number of other countries have been cautioned as Extract Labs implemented a voluntary recall of more than 61,000 units of gummies containing CBD. The U.S. Food and Drug Administration (FDA) has officially designated this recall as Class II, citing possible health effects that are transient or medically reversible for the consumers involved.
Cause of the recall
The recall was prompted when Extract Labs learned of the possibility of peanut protein cross-contact during their manufacturing process. Although peanuts are not an ingredient used in the gummies, they may have come into contact with equipment or surfaces that have been exposed to peanut protein. For the peanut-allergic patient, minute exposure to such proteins is enough to unleash reactions that range from as innocuous as skin rash and gastrointestinal upset to as potentially fatal as anaphylaxis, a condition requiring instant medical intervention.
Recall scope and FDA classification
The recall included exactly 61,460 gummies and was a Class II recall by the FDA on September 22, 2025. This type of classification suggests that there are potential adverse health consequences but typically are transient in nature and are treatable. The recall was initiated on August 26, 2025, but only recently became official to the extent of this classification to alert consumers to danger.
Affected products
Four specific Extract Labs products are recalled, all of which contain both cannabidiol (CBD) and tetrahydrocannabinol (THC). The products have an expiration date of July 2027 and vary in strength and flavor. The sugar-free Mixed Berry Gummies contain 10 mg each of CBD and Δ9 THC and are packaged in bottles with the UPC 850029647928 and lot number 25E5082907A. The last three items — Elderberry, Blue Razz, and Mai Tai Gummies — contain 20 mg of each CBD and Δ9 THC, and are sold in unlabeled bulk containers with lot numbers 25JD072107A (Elderberry), 25JD082307A (Blue Razz), and 25JD042507A (Mai Tai), respectively.
Consumers must review bottles and bulk bag packaging for these precise lot numbers and review the expiration date for uniformity prior to product usage. The Expiration date of Mixed Berry Gummies is printed on the bottle bottom, while it is displayed on the sticky bulk bag label for the other gummies.
International distribution
Although reported in the United States, all of these items were also shipped overseas to the countries of Australia, Germany, the United Kingdom, Malaysia, and New Zealand. Customers in these nations should consult local product information and contact their point of purchase for information regarding refunds or how to dispose of products.
Health risks and recommendation from the FDA
Individuals who are known to suffer from peanut allergies are warned in strong terms against consuming any of the recalled gummies due to the likelihood of allergic reactions. They may lead to skin rash, throat or lip swelling, breathing problem, and, in rare instances, anaphylaxis. The FDA recommends medical attention immediately for anyone who experiences such symptoms.
Non-allergic consumers will most likely not suffer from side effects but are otherwise advised to abide by recall protocols for precautions. Extract Labs and the FDA advise non-allergic consumers to dispose of the products in concern appropriately or return them to a store for refund.
Wider industry implications
This recall highlights the challenges the rapidly expanding CBD market has with quality control and allergen cross-contamination. Most CBD products continue to remain unregulated, and dangers manifest in the form of unidentified ingredients or residue. CBD products’ growing demand for wellness uses such as stress relief, pain management, and sleep aid means that consumers must be vigilant and select goods with transparent manufacturing processes and proven safety.
Through the practices of these principles, consumers can take matters into their own hands and contribute to better safety practices in the supplement and cannabis-derived product space.
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