The reason behind the recall could be anything but relaxing for some 6 million Americans with a particular health condition.
If it feels like cannabidiol products, better known as CBD, have popped up everywhere over the last decade, it’s because they really have—in the form of gummies, tinctures, topical oils, and other goods promising to relax the body, relieve pain, and enable sleep. Now, a total of 61,460 CBD gummies have been recalled nationwide in the U.S. and internationally throughout Australia, Germany, the United Kingdom, Malaysia, and New Zealand. The U.S. Food and Drug Administration (FDA) has named the popular Colorado-based company Extract Labs, Inc. as the recalling firm.
A roundup of FDA Warning Letters for Cannabis-Derived Products, most recently updated earlier this month, suggests that many regulatory concerns involving CBD products are triggered by the companies making unsubstantiated medical claims or including unapproved ingredients, such as THC (the component of marijuana that can produce feelings of “being high”) or food additives, in their formulas. Yet the reason for the FDA’s current gummies recall may surprise some: there was a “potential peanut protein cross-contact,” posing a possible risk to those with peanut allergies.
On September 22, the recall was updated to reflect a Class II designation, suggesting that exposure to the product could cause temporary or reversible harm. However, in addition to more common symptoms such as hives and shortness of breath, the Mayo Clinic says those with severe peanut allergies can suffer from anaphylaxis, which can be life-threatening.
An estimated 6.1 million Americans have a peanut allergy, according to the Cleveland Clinic, and nearly 1.5 million are children. While accidental peanut exposure can be cause for serious concern, CBD gummies—which can strongly resemble candy gummies—can pose another health risk if children accidentally consume them. Says the Children’s Hospital of Orange County: “Although CBD is less likely to make children experience symptoms of a ‘high’ [compared to products with THC], the safety and effectiveness of CBD for children is still being researched.”
The affected products, their quantities, identifying codes, and expiration dates are as follows (mg denotes “milligrams”):
- 2,180 Sugar-free Mixed Berry Gummies (10mg CBD and 10mg D9 THC per gummy); Lot Number/Batch ID: 25E5082907A; Expiration: 07/2027 (printed on the bottom of the bottle)
- 19,720 Elderberry 20mg Gummies (20mg CBD and 20mg D9 THC per gummy); Lot Number: 25JD072107A; Expiration: 07/2027 (printed on bulk bag identifier adhesive)
- 19,810 Blue Razz 20mg Gummies (20mg CBD and 20mg D9 THC per gummy); Lot Number: 25JD082307A; Expiration: 07/2027 (printed on bulk bag identifier adhesive)
- 19,750 Mai Tai 20mg Gummies (20mg CBD and 20mg D9 THC per gummy); Lot Number: 25JD042507A; Expiration: 07/2027 (printed on bulk bag identifier adhesive)
Additional details, including any available UPC, dosage, or packaging information is available at the above FDA recall link.
Despite its soaring popularity in recent years, many people still have their reservations about CBD use: A 2025 Forbes Health survey found that while 60% of adults say they’ve tried CBD products, just 44% say the products should be legal. (It’s worth noting that the U.S. Centers for Disease Control and Prevention lists CBD as “not impairing, meaning it does not cause a ‘high.'”)
Still, consumers should exercise caution since many over-the-counter CBD products are largely unregulated by the FDA, with only a small number of drug products receiving official FDA approval. The health authority writes: “We are concerned that people might mistakenly believe that using CBD ‘can’t hurt’ and that the FDA has evaluated CBD products and determined they’re safe. Data on CBD points to real risks, and the FDA is especially concerned about the risks to children, people who are pregnant or breastfeeding, and people taking other medications. Consumers should be aware of the risks and should speak with a medical provider about the use of any CBD product.”
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