The FDA has announced a nationwide recall of more than 51,000 toothpaste and mouthwash products after testing detected unexpected hormone contamination, including substances associated with hormone replacement therapy.
According to the FDA’s official recall report, Scottsdale, Arizona-based ORL Labs LLC is recalling approximately 51,762 units of its Organic Oral Care products after samples detected progesterone, estradiol or dehydroepiandrosterone (DHEA). The company attributed the issue to cross-contamination.
The recall covers six products, including three toothpastes sold in 4-ounce tubes and three mouthwashes packaged in 16.9-ounce bottles. The affected products were distributed nationwide across the United States.
Which Toothpaste and Mouthwash Products Are Recalled?
The FDA’s recall notice identifies the following products, along with their UPC codes and affected quantities:
Toothpaste:
ORL Organic Oral Care Bubblegum Kids Natural Toothpaste (4 oz.): UPC 850006245505; 3,976 units. ORL Organic Oral Care Cinnamint Toothpaste (4 oz.): UPC 850006245512; 7,202 units. ORL Organic Oral Care Fresh Mint Natural Toothpaste (4 oz.): UPC 850006245499; 19,247 units.Mouthwash:
ORL Organic Oral Care Bubblegum Kids Mouthwash (16.9 oz.): UPC 850006245475; 3,116 units. ORL Organic Oral Care Cinnamint Kids Mouthwash (16.9 oz.): UPC 850006245468; 6,140 units. ORL Organic Oral Care Fresh Mint Mouthwash (16.9 oz.): UPC 850006245451; 12,081 units.The FDA recall information also identifies specific affected lot numbers. Consumers can use these codes, along with the UPC printed beneath each product’s barcode, to check whether their toothpaste or mouthwash is included.
Complete List of Affected Lot Numbers
The recalled products carry expiration dates ranging from September 2026 through August 2028.
The affected lot numbers are:
Bubblegum Kids Natural Toothpaste: 241029P4, 250414P4, 250520P4, 260406P4, 260511P4. Cinnamint Toothpaste: 241209P3, 250129P3, 250508P3, 25112P3, 260511P3. Fresh Mint Natural Toothpaste: 250121P7, 250505P7, 250508P7, 250516P7, 250707P7, 251105P7, 260126P7, 260309P7, 260422P7, 260618P7, 260804P7. Bubblegum Kids Mouthwash: 241029P9, 250505P9, 250520P9, 260406P9. Cinnamint Kids Mouthwash: 241101P10, 241212P10. Fresh Mint Mouthwash: 240710P6, 240711P6, 240807P6, 241118P6, 241121P6, 250120P6, 250505P11, 250516P6, 251105P6, 260618P6.What Consumers Should Know
The FDA’s sampling found the presence of progesterone, estradiol or DHEA in the affected products. Progesterone and estradiol are hormones used in certain contraceptives and hormone replacement therapies, while DHEA is a hormone naturally produced by the adrenal glands.
The recall is particularly noteworthy for parents because three of the six affected products are marketed for children.
The FDA classified the recall as Class II on November 6. This classification means exposure could cause temporary or medically reversible health consequences, although the likelihood of serious adverse health consequences is considered remote.
No illnesses have been reported in connection with the recalled products.
Consumers who purchased the affected products should check their packaging against the recall list. Anyone with a matching product should stop using it and discard it or contact the retailer about a possible return.
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