Mass Recall of Lisinopril in France Due to Printing Error
Over 32,000 boxes of generic hypertension and heart failure medication recalled due to potential overdose risk.
On May 6, 2025, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced the recall of more than 32,000 boxes of Lisinopril, a generic medication used to treat hypertension and heart failure.
This recall was initiated due to a 'printing defect' on the medication packaging, which may lead to a risk of overdose.
The Lisinopril product involved in the recall was manufactured by the U.S.-based company Viatris.
According to the ANSM, 'the quality of the tablets marketed by Viatris is not being called into question'; however, the labeling on the aluminum blister pack could potentially confound patients, suggesting that they should take multiple tablets on certain days.
The recall specifically affects four batches of Lisinopril, each containing 5 mg doses (batches 8172295, 8189879, 8172296, and 8192737), totaling 32,640 boxes.
The agency has warned that overdose symptoms may include fatigue, balance disorders, hypotension, and a possible 'alteration of renal function.' One case of mild confusion associated with overdose has already been reported.
In light of this recall, the ANSM has reassured patients that there is no expected supply shortage of Lisinopril, as alternative formulations are readily available.
Other manufacturers, including Biogaran, Teva, Zentiva, Sandoz, and Arrow, also produce this medication, ensuring continued access for patients requiring treatment for hypertension and heart failure.
New compliant batches of Lisinopril are expected to be available shortly.
This recall was initiated due to a 'printing defect' on the medication packaging, which may lead to a risk of overdose.
The Lisinopril product involved in the recall was manufactured by the U.S.-based company Viatris.
According to the ANSM, 'the quality of the tablets marketed by Viatris is not being called into question'; however, the labeling on the aluminum blister pack could potentially confound patients, suggesting that they should take multiple tablets on certain days.
The recall specifically affects four batches of Lisinopril, each containing 5 mg doses (batches 8172295, 8189879, 8172296, and 8192737), totaling 32,640 boxes.
The agency has warned that overdose symptoms may include fatigue, balance disorders, hypotension, and a possible 'alteration of renal function.' One case of mild confusion associated with overdose has already been reported.
In light of this recall, the ANSM has reassured patients that there is no expected supply shortage of Lisinopril, as alternative formulations are readily available.
Other manufacturers, including Biogaran, Teva, Zentiva, Sandoz, and Arrow, also produce this medication, ensuring continued access for patients requiring treatment for hypertension and heart failure.
New compliant batches of Lisinopril are expected to be available shortly.
