Daye Tampons Lawsuit: FDA Warning, Recall, and Screening Kit

There is no consumer class action against Daye. The legal action around Daye tampons is a federal regulatory matter: on December 17, 2024, the U.S. Food and Drug Administration issued a warning letter to Anne’s Daye Ltd over its CBD-coated tampons and its vaginal microbiome screening kit, and on February 17, 2025, the company began a Class 2 recall of the CBD tampons in the United States.¹² The CBD tampons were pulled from the U.S. market. The screening kit is still being sold on the company’s U.S. website.³

If you found this page while looking for the class actions over lead in tampons, those cases are against Procter & Gamble’s Tampax products, not Daye. That distinction is covered further down.

What the FDA Said Daye Did Wrong

The warning letter followed an inspection of Daye’s Bulgarian manufacturing facility from July 8 to July 11, 2024. It identified violations across two product lines and a broader failure to log consumer complaints.¹

The CBD-Coated Tampons

Daye held a standard 510(k) clearance (K223883) for a tampon, but that clearance covered only “insertion into the vagina to absorb menstrual discharge.” The company was marketing a CBD-coated version for “relief of period related pain,” which the FDA treated as a major change in intended use. The agency cited website copy and a 2022 interview in which founder Valentina Milanova called the product a “pain-relieving tampon.” The FDA declared the CBD tampons both adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.⁴

The FDA had already told Daye in a pre-submission meeting (Q200187) that the 510(k) pathway was not appropriate for a device with a drug component like CBD. The agency said the product would require a premarket approval application or an investigational device exemption. It cited concerns about local and systemic CBD exposure, potential reproductive and developmental toxicity, and quality control issues including possible THC contamination.¹

The Vaginal Microbiome Screening Kit

The FDA also found that Daye’s screening kit was being promoted on the company’s website, Amazon, and Trustpilot with diagnostic claims covering yeast infections, bacterial vaginosis, sexually transmitted infections, urinary tract infections, and fertility complications. Daye classified the kit as a “general wellness device.” The FDA rejected that label, saying diagnostic claims for specific medical conditions require premarket review. The company had been importing the kits under the same K223883 tampon clearance, which the FDA said did not cover a diagnostic product at all.⁵¹

Unlogged Consumer Complaints

The FDA cited Daye for failing to keep proper procedures for receiving and evaluating consumer complaints. The company had responded to health-related complaints about the CBD tampons on Trustpilot but never entered them into its formal quality system. The FDA said complaints of this kind suggested the CBD tampons “may have an impact on the patients’ health (e.g. CBD drug interactions) that exceed the expected risks associated with regular (non-CBD) tampons.”¹

The Recall and Market Withdrawal

The FDA demanded a written response within 15 business days and moved to block Daye’s products at the U.S. border through detention without physical examination.¹

In January 2025, Daye voluntarily removed its CBD-coated tampons from the U.S. market and pulled listings from platforms including Walmart. Milanova said the company was “evaluating alternative pathways for regulatory compliance” and “actively working with the FDA to address their concerns.”⁶

The formal Class 2 recall began on February 17, 2025. The reason listed is that the products lacked 510(k) clearance. The FDA’s database identifies at least three recall entries covering multiple product configurations, including packs of 9 Coated Super Tampons, refill packs of 18 Coated Regular Tampons, and the Initiation 3 Month Regular Flow Bundle. Two of the listings each covered 3,074 packs distributed nationwide.²⁷⁸

Daye emailed affected customers to cancel their CBD tampon subscriptions and offered a $20 credit toward other products on its site, such as its Nude Organic Tampons. As of late 2025, all three recall entries remained listed as “Open” in the FDA’s database.⁸

What About the Screening Kit

The screening kit was removed from Amazon after the warning letter, but it has not been recalled. As of 2026, it is still listed on Daye’s U.S. website for $149.90, with product descriptions continuing to promote screening for bacteria, Candida, Mycoplasma, and Ureaplasma. The listing makes no mention of the FDA warning or any regulatory restrictions.³

Milanova has said the kits are processed in CLIA- and CAP-certified laboratories and have been validated through randomized controlled clinical trials, and that the company’s regulatory consultants believed its clinical evidence gave it a strong foundation to enter the U.S. market. The FDA called the company’s regulatory assessments “inadequate” and rejected the position that no new clearance was needed for either product.⁵¹

How This Differs From the Tampax Lead Lawsuits

Daye’s situation is separate from the class action lawsuits currently moving through federal court over heavy metals in tampons. Those cases target Procter & Gamble’s Tampax products, not Daye.

Barton v. The Procter & Gamble Company (Case No. 3:24-cv-01332) was filed in July 2024 in the U.S. District Court for the Southern District of California. The plaintiffs allege that Tampax Pearl and Tampax Radiant contain lead in amounts that exceed California’s Proposition 65 maximum allowable dose when multiple tampons are used in a day. In August 2025, U.S. District Judge Gonzalo Curiel denied P&G’s motion to dismiss, and the case moved into discovery.⁹ A separate case, Sanchez v. Procter & Gamble, was filed in November 2025 in the Southern District of Ohio, citing lab tests that found lead concentrations in Tampax Pearl products up to 40 times higher than EPA action levels for drinking water.¹⁰

Daye was not accused of contamination. It was accused of marketing products with medical claims and diagnostic uses that its clearance did not cover.

If You Bought the Recalled Product

If you have CBD-coated Daye tampons at home, they are covered by an open Class 2 recall and have been withdrawn from the U.S. market. Daye contacted subscribers directly to cancel CBD tampon subscriptions and offered a $20 credit toward other products on its website.⁸²⁷

If your concern is the screening kit rather than the CBD tampons, the kit has not been recalled and is still on sale, but the FDA has publicly stated that its diagnostic claims are not covered by any clearance.

1
FDA. Warning Letter to Anne’s Daye Ltd DBA Tampon Innovations
2
FDA. Recall — Daye Coated Tampons (Z-0379-2026)
3
Daye. Vaginal Microbiome Test
4
Marijuana Moment. FDA Warns CBD Tampon Company Over Allegedly Misbranded and Adulterated Products
5
MedPage Today. FDA Warns CBD Tampon Company
6
Marijuana Moment. CBD Tampon Maker Pulls Products Off U.S. Market Following FDA Warning Letter
7
FDA. Recall — Daye Coated Tampons (Z-0393-2026)
8
FDA. Recall — Daye Initiation Bundle
9
Top Class Actions. Procter & Gamble Must Face Class Action Lawsuit Over Lead in Tampons
10
AboutLawsuits.com. Tampax Pearl Lawsuit: Toxic Lead in Tampons Enter Bloodstream