With roughly 80% of pharmaceutical ingredients in the U.S. originating from India and China, Valisure was founded with a mission to bring transparency, accountability, and higher quality standards to the drug and consumer health markets. In response to alarming quality issues in the global supply chain, Valisure has submitted multiple FDA Citizen Petitions that have helped reshape national policies, triggered high-profile product recalls, and highlighted serious public health risks.

Carcinogens in Prescription Drugs

• Valsartan & DMF Contamination
  Valisure’s first FDA Citizen Petition, submitted in June 2019, revealed the presence of N,N-Dimethylformamide (DMF)—a probable human carcinogen—in specific lots of valsartan, an angiotensin II receptor blocker (ARB). DMF had been reclassified in 2018 by the World Health Organization (WHO) and International Agency for Research on Cancer (IARC) as a Group 2A carcinogen. Valisure’s findings raised new concerns about the unchecked presence of carcinogens in essential medications.
• Metformin & NDMA Detection
  In March 2020, Valisure detected N-Nitrosodimethylamine (NDMA), another known carcinogen, in 16 out of 38 batches of metformin, a commonly prescribed drug for type 2 diabetes. The contaminated batches were sold by 11 different companies. Valisure’s petition called on the FDA to initiate recalls, ultimately resulting in five companies withdrawing their affected products from the market.
• Zantac (Ranitidine) & NDMA Formation
  Valisure uncovered that ranitidine (Zantac) and its generic equivalents could form NDMA during storage and digestion. This groundbreaking discovery led to one of the FDA’s most sweeping actions to date: the immediate removal of all ranitidine products from U.S. shelves in 2020. This case highlighted the importance of testing not just for contamination, but for chemical instability in active pharmaceutical ingredients.

Widespread Benzene Contamination in Consumer Products

As consumer products were mass-produced during the COVID-19 pandemic—often prioritizing quantity over quality—Valisure expanded its testing in 2020 to include benzene, a known human carcinogen.

• Hand Sanitizers
  In March 2021, Valisure announced that 17% of the 260 hand sanitizer batches tested contained benzene. This discovery prompted an FDA Citizen Petition and ultimately led to product recalls, including items from ArtNaturals and Scentsational Soaps & Candles.
• Sunscreens
  By May 2021, Valisure found benzene in 27% of 294 sunscreen batches tested, prompting recalls of major products from Johnson & Johnson (Neutrogena & Aveeno) and Coppertone. These findings raised concerns about benzene contamination in topical products that are absorbed through the skin.
• Body Sprays
  In November 2021, Valisure’s testing revealed that 54% of 108 antiperspirant body spray batches contained benzene. Recalls soon followed for several well-known Procter & Gamble products, including Old Spice, Secret, Aussie, Herbal Essences, and Waterl<ss.
• Dry Shampoos
  A year later, in November 2022, Valisure found benzene in 60% of the 148 dry shampoo batches tested, further exposing systemic issues in aerosol products and supply chain quality.

A New Risk: Benzene Degrading in Benzoyl Peroxide

Valisure’s most recent findings, announced in March 2024, represent a new and deeply concerning mechanism of benzene exposure. Unlike prior cases where benzene contamination originated from raw materials or propellants, Valisure discovered that benzoyl peroxide (BPO)—an active ingredient in acne treatments—can degrade into benzene under normal conditions. This suggests that benzene formation is inherent to the chemistry of BPO products, and the entire market may be affected. Valisure’s published studies in Environmental Health Perspectives and the Journal of Investigative Dermatology have already garnered attention from major outlets like Bloomberg and Elsevier.

Valisure’s Citizen Petitions continue to catalyze regulatory action and industry reform, reinforcing the need for independent testing and oversight across both drug and consumer product categories. As product safety challenges evolve, so too does Valisure’s commitment to protecting public health through science-driven transparency.

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