Brazil's National Health Surveillance Agency, known as Anvisa, ordered the seizure on Wednesday, November 4, of all batches of Pygeum products sold by six brands. The Brazilian regulator published the decision in the Diário Oficial da União, the federal government's official gazette, on Friday, November 6, under Resolution-RE No. 4,329 of November 4, 2026.
The order covers products marketed as Pygeum Oficialfarma, Unicpharma, Bioformulas, Swanson, Recover Farma, and Nutricost. It also applies to any units sold solely under the name Pygeum without a brand name on the label.
Alongside the seizure, Anvisa banned the storage, sale, distribution, manufacture, advertising, transport, and use of every batch of the targeted products. The restrictions apply to all individuals, businesses, and media outlets in Brazil.
Pygeum is an herbal extract derived from the bark of the African cherry tree, Prunus africana, commonly sold as a dietary supplement. Anvisa, or the Agência Nacional de Vigilância Sanitária, is the federal agency that regulates and approves medicines, supplements, and medical products in Brazil.
Unregistered products and unknown manufacturers
According to the resolution, Anvisa acted after confirming that the Pygeum products were being advertised and listed for sale without registration, notification, or listing with the agency. The regulator also noted that the items were produced by an unidentified manufacturer whose registration number in the Cadastro Nacional da Pessoa Jurídica (CNPJ), Brazil's federal corporate tax registry, is unknown.
Anvisa stated that selling the unregistered items violates Articles 2, 12, and 59 of Brazil's Law No. 6,360/1976, the federal legislation that governs health surveillance for medicines and pharmaceutical inputs. The agency issued the preventive ban under the authority of Article 7, Item XV of Law No. 9,782/1999, the statute that established Anvisa and defined its enforcement powers.
Bacteriostatic water and diluent bans
In the same resolution, Anvisa ordered the seizure of all batches of products advertised as Bacteriostatic Diluent and Bacteriostatic Water. The agency likewise prohibited the storage, sale, distribution, manufacture, advertising, transport, and use of those items.
Bacteriostatic water is sterile water treated with a preservative to inhibit bacterial growth, used in healthcare to dilute or dissolve medications prepared for injection. According to the document, the ban followed proof of sales listings for the products without registration in Anvisa's specific medicines category, and the company manufacturing them was also unidentified.
Counterfeit Mounjaro batches seized
Resolution-RE No. 4,329 also ordered the seizure of counterfeit units of the injectable medication Mounjaro in 2.5 mg, 5 mg, and 15 mg strengths, barring the sale, distribution, and use of the fake products. Mounjaro is the brand name for tirzepatide, a prescription drug developed by the US pharmaceutical maker Eli Lilly for type 2 diabetes and weight management.
Anvisa acted after receiving a formal notice from Eli Lilly do Brasil Ltda., the local subsidiary that holds the Brazilian registration for Mounjaro, reporting that units on the market had characteristics that differed from authentic supplies. The irregularities included batch numbers not recognized by the manufacturer and packaging labels that did not match the company's production standards.
For batch D810042, the resolution specifies that the prohibition applies solely to the identified counterfeit units and does not affect genuine products manufactured regularly by Eli Lilly. Resolution-RE No. 4,329 took effect upon its publication on November 6, and CNN Brasil reported that it had contacted all of the cited brands and was awaiting their responses.
