In France, a massive recall operation is underway affecting a commonly prescribed drug for hypertension. The National Drug Safety Agency (ANSM) has launched a large-scale recall of over 32,000 boxes of Lisinopril, a generic drug widely used to treat high blood pressure and heart failure. This decision, announced on May 6, 2025, follows the discovery of a manufacturing defect that poses potential health risks to patients.
The recall specifically targets Lisinopril marketed by the Viatris laboratory. The reason for this urgent recall is a printing defect on the drug's blister packs. The inscription on the aluminum of the blister packs presents ambiguities that could lead to confusion during medication administration, raising the risk of dosage errors. Authorities have noted that "the inscription on the aluminum can be confusing because it suggests that several tablets should be taken on certain days, which could lead to an overdose by patients," as stated by the ANSM.
The recall is limited to the 5 mg dosage of Lisinopril Viatris, affecting four specific lots: Lot 8172295 (expiration January 2026), Lot 8189879 (expiration March 2027) for boxes of 28 divisible tablets, and Lot 8172296 (expiration January 2026) and Lot 8192737 (expiration March 2027) for boxes of 84 divisible tablets. Patients using the 20 mg dosage can rest assured that it is not impacted by this printing defect.
Health authorities have issued clear recommendations for patients who may possess the affected medication. They strongly advise against abruptly stopping treatment. Instead, patients should return the recalled boxes to their usual pharmacy and request an exchange for a product that is not affected by the recall. Maintaining continuity in treatment is essential for those suffering from hypertension or heart failure, which underscores the importance of promptly exchanging the medication.
Patients are urged to remain vigilant for potential signs of overdose, which may include unusual fatigue, balance disorders, abnormal drops in blood pressure, and issues related to kidney function. Those with pre-existing kidney problems should exercise heightened caution, as they may be more sensitive to the drug's adverse effects. In the event of experiencing these symptoms or any unusual effects, patients are advised to consult a healthcare professional immediately.
This recall highlights the critical importance of clear labeling for chronic treatments, particularly for common conditions like hypertension. The ANSM has emphasized that while the quality of the drug itself is not in question, the labeling defect poses a genuine risk to patient safety.
As the recall process unfolds, the ANSM reassures the public that there will be no supply shortages of Lisinopril, as alternative generic versions of the medication remain available in pharmacies. Viatris has committed to taking all necessary measures to rectify the issue and has begun reviewing its entire packaging chain to prevent such incidents in the future.
In summary, patients are advised to check if their medication is affected by the recall. If so, they should follow the recommended steps to ensure their health and safety. As always, staying informed and in communication with healthcare providers is vital for managing health conditions effectively.
