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Anvisa suspends batches of corticoid and cholesterol drugs due to problems

4 sources · 19 May 2026
2 agreed · 2 partial · 0 conflicts

Your corticoid or cholesterol medication may have been pulled from pharmacies on Monday (18th). Anvisa suspended the commercialization of specific batches of three medications — injectable dexamethasone from Hypofarma and two cholesterol drugs from Cimed — after the laboratories themselves identified quality problems and initiated voluntary recalls.

Press quotes (1)
Agência Brasil

"A Agência Nacional de Vigilância Sanitária (Anvisa) suspendeu nesta segunda-feira (18) a comercialização, distribuição e uso de medicamentos depois de notificações de problemas em lotes específicos de produtos fabricados pelos laboratórios Hypofarma e Cimed."

Batch 25091566 of Dexamethasone Disodium Phosphate 4 mg/ml (anti-inflammatory corticoid used in hospitals) was recalled after Hypofarma identified darkening of the solution when diluted with certain medications. Cimed recalled batch 2424299 of Atorvastatin calcium 40mg and Rosuvastatin 20 mg due to suspected package mixing — Rosuvastatin cartridges were allegedly identified in Atorvastatin batches.

Press quotes (2)
Agência Brasil

"A empresa informou o recolhimento voluntário do lote 25091566 após identificar escurecimento da solução quando o produto é diluído em associação com determinados medicamentos."

Agência Brasil

"Já a Cimed comunicou o recolhimento voluntário do lote 2424299 dos medicamentos Atorvastatina cálcica 40mg e Rosuvastatina 20 mg, ambos utilizados para controle do colesterol. Segundo a empresa, houve suspeita de mistura de embalagens com cartuchos de Rosuvastatina identificados em lote de Atorvastatina."

Anvisa also banned the commercialization of 14 herbal products without sanitary registration on Monday, including items with names like "Cure-All Compound," "Seu Geraldo's Bottle," and "Stud Compound." The measure affects all batches of the products, which lack notification or registration with the regulatory agency.

Press quotes (1)
Agência Brasil

"A agência sanitária também informou hoje que determinou a apreensão e proibiu a fabricação, comercialização, distribuição, importação, propaganda e uso de uma série de medicamentos e fitoterápicos sem registro, notificação ou cadastro sanitário."

1. What we know (2)

Anvisa suspended three specific batches of medications from two laboratories on May 18, 2026, after voluntary recall

4 sources Agência Brasil Jovem Pan O Povo A Crítica

Hypofarma and Cimed laboratories initiated voluntary recalls before Anvisa's official decision

3 sources Agência Brasil Jovem Pan O Povo
2. Where coverage thins out (2)

Covered by only some sources, or where the accounts diverge.

Covered by only some sources (2)

The decision was published in the Official Gazette on Monday

Reported by: Jovem Pan

Patients and healthcare professionals should verify batch numbers before use

Reported by: Jovem Pan
3. What we don't know yet (4)
  • What is the specific legal basis that authorizes Anvisa to suspend batches of registered medications?

    Why it's still unknown: Reports cite the suspension but do not identify the specific resolution, ordinance or law that supports the regulatory decision

  • How many commercial establishments and patients are directly affected by the suspended batches?

    Why it's still unknown: No source presents estimates of batch distribution or number of units in circulation

  • What is the scientific cause of dexamethasone darkening and whether this represents a health risk?

    Why it's still unknown: Sources report the darkening but do not explain whether there is associated clinical risk or just aesthetic problems

  • Are there ongoing legal challenge procedures against Anvisa's decision?

    Why it's still unknown: No source mentions whether laboratories or distributors have contested the suspensions administratively or judicially

All sources

4