Brazil’s National Health Surveillance Agency (Anvisa) has ordered the recall of specific batches of medicines after regulatory inspections uncovered packaging irregularities and counterfeit products that pose risks to supply chain integrity and patient safety.
The regulatory action in early January highlights growing concerns over packaging compliance, quality assurance and the proliferation of falsified medicines in the pharmaceutical market.
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Recall orders linked to packaging mistakes in branded medicines
Anvisa’s latest action targets multiple lots of authorised medicines affected by packaging errors.
The recall of Pantoprazol Sódico Sesqui-Hidratado 40 mg (lot OA3169), a drug used to treat gastrointestinal conditions, followed reports from the manufacturer MedQuímica that the outer carton bore the packaging for a different medicine – Hidroclorotiazida 25 mg – used for hypertension. Anvisa suspended the distribution, sale and use of this specific lot.
In a separate case, the antiallergic product Alektos 20 mg (lot 569889) was also recalled after its packaging was found to show the label of Nesina, a different pharmaceutical product.
This type of packaging mismatch can cause serious medication errors if left undetected in the supply chain.
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By GlobalDataThese recalls emphasise the importance of accurate labelling and packaging control as integral aspects of pharmaceutical quality systems. Packaging errors not only undermine regulatory compliance but can also lead to incorrect dosing or unintended drug administration.
Industry stakeholders increasingly view packaging compliance as a critical part of risk management in medicine manufacturing.
Seizure of falsified lots highlights counterfeit packaging risks
Beyond irregular packaging, Anvisa’s enforcement included the seizure and prohibition of counterfeit medicine lots, where packaging was a key indicator of fraud.
Several lots of the oncology drug Imbruvica (lots NIS7G01, NJS7J00 and PJS0B00) were declared falsified; the registered manufacturer confirmed it had not produced these batches, and they have been barred from sale, distribution and use in Brazil.
Similarly, a batch of Mounjaro (lot D838878) and products marketed as Voranigo were identified as non-genuine and ordered seized by the regulatory agency.
These measures reflect a wider trend of counterfeit packaging being used to circulate unauthorised medicines that evade regulatory scrutiny, a recognised challenge in global pharmaceutical supply chains.
Implications for packaging compliance and industry oversight
The recent enforcement actions stress the strategic role of packaging quality control and anti-counterfeit measures in pharmaceutical regulation.
For B2B stakeholders, these events underline the need for robust packaging validation, serialization and traceability systems that can detect and prevent mismatches before products reach customers or patients.
Regulatory experts note that packaging issues – whether mislabelling, incorrect cartons or counterfeit seals – can lead to costly recalls, disrupt supply chains and damage brand integrity.
Ensuring compliance with local and international standards, including digital tracking and unique identifiers, is increasingly viewed as essential for manufacturers, distributors and contract packagers operating in or entering regulated markets such as Brazil.
