Anvisa Suspends Enalapril and Halaven Lots After Manufacturers Report Quality and Labeling Faults

Overview

• Anvisa published Resolução 2.238/2026 that suspends sale, distribution and use of nine hospital-pack lots of Maleato de Enalapril 20 mg and Halaven lot 148386 to protect patients.
• Hipolabor notified the agency of a textual inconsistency on secondary enalapril packaging that wrongly lists “10 mg” instead of the correct “20 mg,” and the company began a voluntary recall.
• United Medical reported that Halaven lot 148386 had a level of active ingredient below the approved specification and initiated a voluntary recall that prompted Anvisa’s suspension.
• Health services were instructed to stop using the affected lots and follow manufacturers’ return and replacement procedures, and the agency also suspended an infusion water lot after Adolfo Lutz tests and ordered seizure of unregistered pequi oil capsules.
• The June 2 decision focuses on preventing dosing errors in hospitals where printed packaging guides dispensing, and patients with suspended products are advised to contact their clinician, pharmacist or the manufacturers’ SAC for guidance.