✓ verbatim from the press
Anvisa — Brazil's drug control agency — removed 10 batches of hypertension and breast cancer medications from the market due to quality problems. Resolution 2.238/2026, published June 2 in the Official Gazette, suspends sale, distribution and use of the products until further notice. ✓
Press quotes (1)
"A Agência Nacional de Vigilância Sanitária (Anvisa) suspendeu a venda, distribuição e consumo de medicamentos para controle de pressão e tratamento de câncer de mama. A Resolução 2.238/2026 foi publicada hoje (2) no Diário Oficial da União (DOU)."
The cancer medication is Halaven (eribulin mesylate), used in chemotherapy for breast cancer. Manufacturer United Medical reported voluntary recall of batch 148386 because the active ingredient content was below approved specification — meaning the drug may have less active substance than necessary for treatment. ✓
Press quotes (1)
"Um dos medicamentos é o Halaven (mesilato de eribulina) - 0,5mg/ml sol inj ct fa vd trans x 2ml, fabricado pela farmacêutica United Medical Ltda e utilizado para tratamento de câncer. A empresa comunicou o recolhimento voluntário do Lote 148386 em razão de desvio de qualidade, relacionado ao teor do princípio ativo que estaria abaixo da especificação aprovada."
The hypertension medication is enalapril maleate 20 mg from Hipolabor Farmacêutica, used for high blood pressure and heart failure. The problem here was labeling error: packages indicate "10 mg" in the composition description, when it should be "20 mg". Nine batches are suspended, all with codes ending in "26M" — indicating 2026 manufacture. ✓
Press quotes (1)
"O outro medicamento é o maleato de enalapril - 20 mg com ct bl al plas trans x 500 (emb hosp), da fabricante Hipolabor Farmacêutica Ltda, usado no tratamento de hipertensão e insuficiência cardíaca. A Anvisa informa que houve um erro em relação às embalagens do produto. As embalagens apresentam equivocadamente a indicação de "10 mg" na descrição de composição, ao invés de "20 mg", que seria a descrição correta."
Anvisa advises patients who have these medications at home to stop use immediately and seek doctor or pharmacist guidance on substitution. The agency also ordered suspension of one batch of infusion water from Indústria Farmacêutica S/A and seizure of pequi oil capsules from R.T.K Indústria for lack of registration. ✓
Press quotes (1)
"Aqueles que têm em casa os medicamentos vetados pela Anvisa devem interromper imediatamente o uso. O indicado é entrar em contato com um médico, farmacêutico ou outro responsável pelo tratamento para orientações."
Resolution 2.238/2026 was published in DOU on June 2, 2026
United Medical reported voluntary recall of Halaven batch 148386
Covered by only some sources, or where the accounts diverge.
No gaps or divergences found — sources converge.
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What is the full text of Anvisa Resolution 2.238/2026?
Why it's still unknown: Attempt to obtain primary document from DOU failed — only press reports cite the resolution
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How many patients are using the suspended batches and need substitution?
Why it's still unknown: Anvisa and manufacturers did not release estimates of affected patients
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Are there alternative medications available to replace the suspended batches?
Why it's still unknown: Sources do not address availability of alternatives in SUS or private network for affected active ingredients
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How did United Medical detect the quality deviation in Halaven?
Why it's still unknown: Company reported voluntary recall but did not detail process of detecting the problem