# Brazil ANVISA expands product safety enforcement

> Live situation record from CLSTR: https://clstr.news/situations/brazil-anvisa-drug-batch-recalls
> Updated: 2026-08-09T17:48:00.000Z. Sources: 174. Developments: 22.

Since May 2026, Brazil’s National Health Surveillance Agency (ANVISA) has intensified enforcement of sanitary rules for pharmaceuticals, cosmetics, and other consumer goods. Early actions included suspending batches of statins, dexamethasone, enalapril, and the oncology drug Halaven; recalling infant formula (Essentia Pharma), injectable antibiotics (Polycid and clindamycin phosphate), and saline solution (Equiplex) due to contamination or quality defects. 

In June, the agency prohibited unregistered herbal drugs, banned formaldehyde and glioxilic acid in hair-straightening products, and seized illegal e-cigarettes via Operation Rede de Fumaça. ANVISA also suspended the Voy obesity-treatment platform for lacking medical-software registration, and recalled Artro100 supplements and Idn Labs creatine gummies. Regulatory focus expanded to include medical supply storage standards and new cosmetic ingredient restrictions (RDC 1.029/2026).

Throughout July, enforcement targeted contaminated mineral water (Mamba Water), energy drinks (Mister Hemp), and illegal weight-loss pens containing the experimental drug retatrutida, which has seen millions in counterfeit seizures at the border. ANVISA also addressed counterfeit Mounjaro 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 broad crackdown on unregistered, falsified, or substandard medicines, cosmetics, and dietary supplements to mitigate risks of infection, heart complications, and ineffective treatment.

## Claims

- Anvisa ordered the seizure of a falsified Mounjaro batch on 30 July 2026. (disputed by 19 sources)
- The seizure applies only to Mounjaro units with lot D881474 and serial 302199651396; other units of the same lot are unaffected. (disputed by 17 sources)
- Manufacturer Eli Lilly do Brasil discovered the incompatibility and reported it to Anvisa. (corroborated by 19 sources)
- Mounjaro is a tirzepatide‑based GLP‑1 agonist used for diabetes and weight‑loss treatment. (corroborated by 19 sources)
- Consumers are urged to obtain medicines only from regulated pharmacies, keep invoices and verify packaging. (corroborated by 19 sources)
- Use of the falsified product could cause serious therapeutic failure or unpredictable adverse reactions. (corroborated by 19 sources)
- Anvisa advises that the product must not be distributed, sold, or used. (corroborated by 18 sources)
- The recall applies nationwide across Brazil. (corroborated by 10 sources)

## Timeline

### 2026-08-09: Anvisa bans six types of unregulated salt products in Brazil

Anvisa has banned and ordered the seizure of six unregulated salt products from the brand Quanqton in Brazil due to clandestine manufacturing and deceptive health claims.

10 sources. https://clstr.news/cluster/anvisa-bans-six-irregular-salt-brands-in-brazil

### 2026-07-31: Brazil's Anvisa suspends multiple medical and consumer products over safety concerns

Anvisa has suspended or recalled dozens of medical, pharmaceutical, food and cosmetic products in Brazil over safety and regulatory violations, affecting manufacturers and consumers nationwide.

15 sources. https://clstr.news/cluster/brazils-anvisa-suspends-sale-of-bio-aid-catheter-dressing-and-bd-abiocat-catheter

### 2026-07-29: Brazil's Anvisa orders recall of Paramol batch and seizes counterfeit Mounjaro

Anvisa recalled a mold‑contaminated Paramol batch and seized counterfeit Mounjaro units with an illegal serial number, urging consumers to stop use and verify authenticity.

55 sources. https://clstr.news/cluster/anvisa-bans-hair-cream-artisanal-cheese-and-pesto-sauce-in-brazil

### 2026-07-27: Brazil's Anvisa warns that counterfeit weight‑loss injection pens threaten heart health

Brazil's Anvisa warns that fake weight‑loss injection pens sold online can cause arrhythmias and heart attacks, urging consumers to avoid unregistered products.

2 sources. https://clstr.news/cluster/brazils-anvisa-warns-that-counterfeit-weightloss-injection-pens-threaten-heart-health

### 2026-07-26: Retatrutida remains unapproved as Brazil seizes over R$11 million of illegal shipments

Retatrutida, an unapproved experimental obesity drug, was seized by Brazilian authorities in illegal shipments from Paraguay worth over R$11 million in early 2026, highlighting health risks and lack of approval

4 sources. https://clstr.news/cluster/retatrutida-remains-unapproved-as-brazil-seizes-over-r11-million-of-illegal-shipments

### 2026-07-24: Brazil's Anvisa warns against illegal retatrutida weight‑loss pens

Anvisa warns that experimental obesity drug retatrutida, still unapproved worldwide, is being sold illegally in Brazil, with seizures exceeding R$ 11 million in early 2026 and serious health risks.

14 sources. https://clstr.news/cluster/brazils-anvisa-bans-dozens-of-cosmetics-and-food-products-over-safety-violations

### 2026-07-16: Brazil's Anvisa recalls Mamba Water batches over contamination

Brazil's health regulator Anvisa recalled Mamba Water cans (lots 13‑14) after detecting Pseudomonas aeruginosa and suspended all Mister Hemp energy drinks over safety and registration failures.

37 sources. https://clstr.news/cluster/brazils-anvisa-orders-recall-of-mamba-water-mineral-water-and-mister-hemp-energy-drinks

### 2026-07-03: Brazil's ANVISA issues new rules on cosmetic ingredient restrictions

ANVISA released new resolutions restricting and prohibiting certain cosmetic ingredients, opened a public consultation for further restrictions, and continues its broader role regulating health‑related products

2 sources. https://clstr.news/cluster/brazils-anvisa-issues-new-rules-on-cosmetic-ingredient-restrictions

### 2026-07-02: Brazil's Anvisa suspends Dobutamine drug and bans products from five firms

Anvisa has suspended the dobutamine drug over quality concerns and banned supplements from five firms for safety and registration violations.

2 sources. https://clstr.news/cluster/brazils-anvisa-suspends-dobutamine-drug-and-bans-products-from-five-firms

### 2026-06-30: Brazil's Anvisa orders recall of repellent batch and several cosmetics

Anvisa in Brazil has recalled a repellent batch that failed IR3535 efficacy tests and suspended several DC Biocosméticos cosmetics and all products bearing ATSUM’s label for lacking proper sanitary registration

2 sources. https://clstr.news/cluster/brazils-anvisa-orders-recall-of-repellent-batch-and-several-cosmetics

### 2026-06-29: Brazil's Anvisa bans digital health platform, recalls repellent, cosmetics and industrial kerosene

Anvisa shut down the Voy telehealth platform, recalled a faulty Repele repellent batch, blocked unregistered DC Biocosméticos cosmetics, and ordered a nationwide recall of Querosene Petrus cleaning product.

11 sources. https://clstr.news/cluster/brazils-anvisa-bans-dc-biocosmticos-cosmetics-and-voy-telemedicine-platform

### 2026-06-26: Anvisa seizes Artro100 supplement and recalls creatine gum batches

Anvisa seized the Artro100 supplement and recalled Idn Labs' creatine‑gum batches (lots 0061/02/2026, 0367/11/2025, 0012/01/2026) due to composition, labeling and unauthorized health‑claim issues.

2 sources. https://clstr.news/cluster/anvisa-seizes-artro100-supplement-and-recalls-creatine-gum-batches

### 2026-06-26: Anvisa bans Voy weight‑loss platform for lacking medical‑software registration

Anvisa prohibited the Voy obesity‑treatment platform for missing medical‑software registration and pharmacy authorization, warning of unsafe drug sourcing; Voy says it will stay online pending appeal.

8 sources. https://clstr.news/cluster/anvisa-bans-voy-obesity-treatment-platform

### 2026-06-24: Anvisa bans obesity‑treatment platform Voy and suspends Artro100 supplement and creatine gummies

Anvisa suspended the Voy obesity‑treatment platform for lacking medical‑device registration and banned the Artro100 supplement and certain creatine‑gum batches due to unknown composition, illegal health claims,

36 sources. https://clstr.news/cluster/brazils-anvisa-bans-artro100-supplement-and-suspends-idn-labs-creatine-gummies

### 2026-06-24: Brazil's Anvisa Tightens Hair‑Straightening Product Rules

Anvisa bans formaldehyde and glioxilic acid in hair‑straightening products, enforces registration, and highlights health risks, while France urges EU limits on Brazilian‑style straighteners.

3 sources. https://clstr.news/cluster/brazils-anvisa-tightens-hairstraightening-product-rules

### 2026-06-24: Anvisa seizes over 25,000 illegal electronic cigarettes in Brazil

Anvisa and Receita Federal seized over 25,000 illegal e‑cigarettes and 107,000 contraband cigarette packs nationwide, citing health risks to youth and enforcing the ban under RDC 855/2024.

8 sources. https://clstr.news/cluster/brazil-health-agency-and-tax-authority-seize-25000-illegal-ecigarettes

### 2026-06-24: Brazilian health agencies urge clinics to tighten medical supply storage

Brazil’s growing medical‑product market is prompting Anvisa and experts to push clinics for better temperature, humidity and documentation controls to keep supplies safe.

4 sources. https://clstr.news/cluster/brazilian-health-agencies-urge-clinics-to-tighten-medical-supply-storage

### 2026-06-18: Brazil's Anvisa recalls antibiotics and saline solution over quality defects

Anvisa recalled two antibiotics—Polycid with a glass fragment and clindamycin with discoloration/particles—and a saline solution due to quality deviations, urging immediate removal from use.

19 sources. https://clstr.news/cluster/brazils-anvisa-bans-several-dietary-supplements-over-safety-concerns

### 2026-06-10: Brazil's Anvisa orders recall of Essentia Pharma infant formula

Anvisa ordered a nationwide recall of Essentia Pharma infant formula made by HKM Farmácia, citing lack of registration and misleading labels that could endanger infants.

2 sources. https://clstr.news/cluster/brazils-anvisa-orders-recall-of-essentia-pharma-infant-formula

### 2026-06-06: Brazil's Anvisa extends digital prescription deadline and bans three consumer products

Anvisa delayed its digital prescription system to Sept 30 2026 and banned a Colgate toothbrush, a Sócio Rico perfume and a sodium percarbonate bleach over registration issues.

2 sources. https://clstr.news/cluster/brazils-anvisa-extends-digital-prescription-deadline-and-bans-three-consumer-products

### 2026-06-02: Brazil's Anvisa suspends medication lots, seizes cosmetics

Anvisa halted specific hypertension and breast‑cancer drug batches for quality issues and ordered the seizure of unregistered cosmetics, banning their sale and use in Brazil.

2 sources. https://clstr.news/cluster/brazils-anvisa-suspends-medication-lots-seizes-cosmetics

### 2026-05-18: Brazil's Anvisa suspends specific statin and dexamethasone batches

Anvisa halts specific statin and dexamethasone batches over packaging mix‑up and solution issues, also bans unregistered herbal medicines.

8 sources. https://clstr.news/cluster/brazil-recalls-statin-batches-after-packaging-mixup

---
Cite as: Brazil ANVISA expands product safety enforcement. CLSTR, https://clstr.news/situations/brazil-anvisa-drug-batch-recalls
