Advisory: FDA Issues Class II Recall of 60,000 CBD Gummies for Undeclared Allergen

The US Food and Drug Administration (FDA) has announced a voluntary recall of over 60,000 cannabidiol (CBD) gummies made by Extract Labs. These products are being recalled due to the potential contact with peanut protein, which poses a serious risk to individuals with peanut allergy. The affected gummies were widely distributed not only across the US but also in several international markets, including Australia, Germany, the United Kingdom, Malaysia, and New Zealand.

Although the recall was initiated on August 26, 2025, the FDA escalated its designation to Class II, meaning that consuming the product may lead to “temporary or medically reversible adverse health consequences.” While less likely to cause severe, long-term harm, consumers with known peanut allergies must exercise caution and avoid these particular items.

For people allergic to peanuts, even tiny amounts can cause dangerous reactions. Common symptoms include skin irritations, digestive problems, and difficulty breathing. The most serious risk is anaphylaxis, a life-threatening condition. Anyone showing signs of anaphylaxis should immediately use prescribed epinephrine or call 911 for emergency help.

It is important to note that the gummies were not made with peanuts as an ingredient. Instead, the recall stems from potential peanut protein cross-contact, meaning the gummies may have encountered shared surfaces, manufacturing equipment, or other materials that also came into contact with peanuts. This process could transfer trace, allergenic amounts onto the finished product, which is enough to cause a reaction in a severely allergic person.

Four specific products from Extract Labs are currently subject to this recall. All of these gummies contain both CBD and D9 THC, a detail that may affect their distribution and legality depending on the state. The recalled items are:

• Sugar-free Mixed Berry Gummies (10mg CBD and 10mg D9 THC)
  • UPC: 850029647928
  • Lot: 25E5082907A
  • Expiration Date: 07/2027
• Elderberry 20mg Gummies (20mg CBD and 20mg D9 THC)
  • Lot: 25JD072107A
  • Expiration Date: 07/2027
• Blue Razz 20mg Gummies (20mg CBD and 20mg D9 THC)
  • Lot: 25JD082307A
  • Expiration Date: 07/2027
• Mai Tai 20mg Gummies (20mg CBD and 20mg D9 THC)
  • Lot: 25JD042507A
  • Expiration Date: 07/2027

Lot numbers and expiration dates are printed either on the bottom of the bottle or on a bulk bag adhesive, depending on the specific product.

Consumers with a peanut allergy who have purchased any of the listed products should not consume them under any circumstances. The best action is to dispose of the gummies or return them to the place of purchase for a possible refund.