Massive recall of a drug for hypertension and heart failure in France

More than 32,000 boxes of a generic drug for hypertension and heart failure, Lisinopril , have been recalled in France due to a "printing defect" on the blister packs "which could lead to a risk of overdose " , the French National Agency for the Safety of Medicines (ANSM) announced on Tuesday, May 6.

The quality of the tablets marketed by the American laboratory Viatris "is not in question" but "the inscription on the aluminum foil of the blister pack can be misleading because it suggests that several tablets should be taken on certain days," ANSM stated in a press release.

In total, four batches of Lisinopril dosed at 5 mg are affected (batches 8172295, 8189879, 8172296, 8192737), or 32,640 boxes, according to a count obtained from the ANSM.

Fatigue, balance problems, hypotension...

In case of overdose, fatigue, balance disorders, hypotension and " impairment of renal function may occur" are possible, warns the drug guardian.

A case of overdose accompanied by a non-serious confusional state has been reported, according to the ANSM.

"Available" alternatives

Until new batches with compliant blister packs are "soon available" , no supply shortage of Lisinopril is expected following this recall, according to the agency, because "alternatives are available".

Other generic manufacturers, such as Biogaran , Teva , Zentiva , Sandoz or Arrow offer this molecule, according to the Vidal database on drugs in France.