BRAZIL · HEALTH
Key Facts
- The country Brazil, where the health regulator Anvisa polices medicines, food and medical devices nationwide.
- What happened Anvisa suspended three single drug batches on Wednesday 28 October 2026, two of them cancer infusions.
- The cancer drugs Simbeva (Teuto) and Abevmy (Biocon), one lot each, failed a bacterial endotoxin test.
- Patients The order covers sale, distribution and use; the resolution names no shortage and no US shipments.
- Power Index Brazil ranks 1st of 14 in The Rio Times Latin America Power Index, with 75.0 points (October 2026 edition).
Brazil’s health regulator Anvisa suspended three drug batches on Wednesday 28 October 2026, and two of them are infusions given to cancer patients. The order covers one lot each of the cancer drugs Simbeva and Abevmy, plus one lot of a hospital fluid.
Anvisa, short for Agência Nacional de Vigilância Sanitária, is Brazil’s counterpart to the US Food and Drug Administration. For American readers the order is a regional safety story, because the resolution names no shipment to the United States.
What Happened
Anvisa signed Resolution RE 4,231 on Tuesday 27 October 2026, and the federal gazette, the Diário Oficial da União, published it on Wednesday 28 October. It lists three companies and one batch for each.
The first is lot BF25008896 of Simbeva, a 25 mg/ml infusion in a 16 ml vial made by Laboratório Teuto Brasileiro. The second is lot BF26002105 of Abevmy, the same strength and vial size, sold by Biocon Biologics do Brasil.
Both companies started a voluntary recall after a test came back outside specification for bacterial endotoxins. Endotoxins are fragments of bacteria that can cause fever and shock when they reach the bloodstream, so injectable drugs must stay below a strict limit.
The third batch is lot M 0465 26 of Ringer’s lactate, a 500 ml plastic bag made by JP Indústria Farmacêutica. It is a standard saline-type fluid that hospitals use to replace lost body fluids, not a cancer drug.
Why It Matters
Cancer infusions go straight into a vein, so a contamination signal in one lot can harm weak patients. Anvisa treats an endotoxin result outside the limit as a breach of RDC 658/2022, its standard on manufacturing quality.
For the two cancer drugs, Anvisa suspended sale, distribution, export and use, which means no vial of those lots should be given to any patient. For the fluid bag, it suspended sale, distribution and use after the Instituto Adolfo Lutz, a state public-health laboratory in São Paulo, tested a sample.
The Lutz laboratory found dark particles of various sizes floating in the bag, which failed the visual inspection test. Anvisa based the order on Law 6,360 of 1976 and on RDC 625/2022.
These drug batches follow other recent moves by the regulator. Read our reports on Anvisa’s limits on polilaminina and on two new cancer drugs approved in Brazil.
What It Means for You
If you receive cancer treatment in Brazil, your oncology team or hospital pharmacy checks the lot number on the vial. Do not stop treatment on your own, because other lots of the same drugs are not part of the order.
Hospitals and pharmacies must stop dispensing the listed drug batches and check their stock against the lot numbers. A patient who feels fever, chills or dizziness after an infusion should tell the care team at once.
For readers in the United States, nothing in the resolution links these lots to the US market. The listed products are Brazilian presentations, and Anvisa names no export destination.
What Is Not Known
The resolution does not say how many vials each lot holds, how many reached hospitals, or whether any patient was harmed. It also does not say whether a lot was exported, although export is suspended for the two cancer drugs.
Anvisa gives no sign of a shortage, and the order covers one lot per product. It is not known whether the companies will replace the recalled lots soon or whether the regulator will widen the order to more drug batches.
More: Brazil news in English, every day from The Rio Times.
Frequently Asked Questions
Which cancer drugs did Brazil suspend?
Anvisa suspended lot BF25008896 of Simbeva, made by Laboratório Teuto Brasileiro, and lot BF26002105 of Abevmy, sold by Biocon Biologics do Brasil. Both are 25 mg/ml infusions in 16 ml vials.
Why were the batches suspended?
The two cancer drugs failed a bacterial endotoxin test, and their makers began voluntary recalls. The Ringer’s lactate bag showed dark floating particles in a state laboratory test.
Should patients stop their cancer treatment?
No. Only the listed lots are affected, so patients should ask their hospital pharmacy to check the lot number. Anyone with fever or chills after an infusion should contact the care team.
Sources: Anvisa, Resolução-RE nº 4.231 of 27 October 2026, Diário Oficial da União, Section 1, page 132 (28 October 2026), 28 October 2026; Anvisa, National Health Surveillance Agency, medicines enforcement page, 28 October 2026.
This article was produced by The Rio Times’ automated newsroom system. How we use AI · Report an error · Editorial responsibility: Matthias Camenzind, Editor-in-Chief
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