[REVISION HISTORY]

Brazil ANVISA expands product safety enforcement

Updated 8 times since CLSTR started tracking revisions of this situation.

What changed

2026-08-01 14:52 UTC → 2026-08-09 20:32 UTC · added ~~removed~~

Since May ~~2026~~ 2026, Brazil’s National Health Surveillance Agency (ANVISA) has intensified enforcement of sanitary rules for pharmaceuticals, ~~cosmetics~~ cosmetics, and other consumer goods. Early actions ~~suspended~~ included suspending batches of statins, dexamethasone, ~~enalapril~~ enalapril, and the oncology drug ~~Halaven, seized unregistered cosmetics and cleaning agents, delayed a digital‑prescription system and recalled~~ Halaven; recalling infant ~~formula,~~ formula (Essentia Pharma), injectable antibiotics (Polycid and a clindamycin phosphate), and saline solution ~~for~~ (Equiplex) due to contamination or quality defects. In ~~June~~ June, the agency ~~issued storage guidance for clinics,~~ prohibited unregistered herbal drugs, banned formaldehyde and glioxilic acid in ~~hair‑straightening~~ hair-straightening products, ~~reaffirmed bans on the Artro100 supplement~~ and ~~Idn Labs creatine‑gummy products,~~ seized illegal ~~e‑cigarette devices, shut down~~ e-cigarettes via Operation Rede de Fumaça. ANVISA also suspended the ~~unregistered online obesity‑treatment~~ Voy obesity-treatment platform ~~Voy, and recalled DC Biocosméticos cosmetics~~ for lacking ~~registration~~ medical-software registration, and making therapeutic claims. July saw the prohibition of all Mister Hemp energy‑drink products for missing stability data, a voluntary recall of two Mamba Water mineral‑water batches contaminated with *Pseudomonas aeruginosa*, recalled Artro100 supplements and ~~continued~~ Idn Labs creatine gummies. Regulatory focus ~~on microbial contamination in Ypê detergent and Crystal mineral water. On 24 July ANVISA prohibited manufacture, sale, advertising~~ expanded to include medical supply storage standards and ~~use of dozens of~~ new cosmetic ~~items lacking registration or containing non‑approved formulations, listed specific perfumes and hair‑straightening masks,~~ ingredient restrictions (RDC 1.029/2026). Throughout July, enforcement targeted contaminated mineral water (Mamba Water), energy drinks (Mister Hemp), and ~~ordered seizure of Profuse Nitrel Suavizante Balm batches sold via Shopee. The regulator also warned against~~ illegal ~~weight‑loss~~ weight-loss pens containing the experimental drug ~~retatrutida and seized more than R$ 11 million of~~ retatrutida, which has seen millions in counterfeit ~~pens~~ seizures at the ~~Foz do Iguaçu~~ border. ~~In late July~~ ANVISA ~~ordered the recall of a batch of Paramol 750 mg tablets (lot 114053) after mold contamination was detected, urging patients to stop use and seek refunds. The agency~~ also ~~seized~~ addressed counterfeit ~~units of the diabetes/obesity drug~~ Mounjaro ~~(tirzepatide) bearing unauthorized serial numbers, issuing~~ and mold-contaminated Paramol tablets. By August, the agency continued seizures of unregistered products, including various salt brands sold with prohibited health claims, medical devices (Bio-Aid and BD Abiocat), and several aesthetic products. Ongoing measures reflect a ~~nationwide warning~~ broad crackdown on unregistered, falsified, or substandard medicines, cosmetics, and dietary supplements to ~~purchase medicines only from authorized pharmacies.~~ mitigate risks of infection, heart complications, and ineffective treatment.

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