30,000 boxes of heart and blood pressure tablets recalled in France
France's national authority for regulating medicine, the
Agence nationale de sécurité du médicament
(ANSM) published a statement recalling thousands of boxes of Lisinopril, a medicine that treats high blood pressure.
In a
statement
published on Tuesday, the ANSM explained that the recall was due to a printing defect.
"We have been informed by the Viatris laboratory of a printing defect on the blister packs of several batches of Lisinopril 5mg breakable tablets, which may lead to a risk of overdose.
"The inscription on the aluminium blister pack may be confusing, as it suggests that several tablets should be taken on certain days (...)
There is therefore a risk of patients taking too many tablets," they wrote.
According to the ANSM, risks in the event of an overdose include fatigue, balance problems, hypotension, and impaired kidney function.
A total of four batches of Lisinopril 5mg, or 32,640 boxes, are being recalled.
These are batch number 8172295 (28 tablets expiring in January 2026), 8189879 (28 tablets expiring in March 2027), 8172296 (84 tablets expiring in January 2026) and 8192737 (84 tablets expiring in March 2027).
Patients are asked to return affected boxes to their pharmacy.
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ANSM also said 'the quality of the tablets [in the affected batches] is not in question'. The recall was solely to prevent possible overdoses prompted by the misprinted packaging.
If you are concerned your medication could be affected by a recall, you can always take it to your local pharmacy and ask the pharmacist for their advice.
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Local France
07-05-2025
- Local France
30,000 boxes of heart and blood pressure tablets recalled in France
France's national authority for regulating medicine, the Agence nationale de sécurité du médicament (ANSM) published a statement recalling thousands of boxes of Lisinopril, a medicine that treats high blood pressure. In a statement published on Tuesday, the ANSM explained that the recall was due to a printing defect. "We have been informed by the Viatris laboratory of a printing defect on the blister packs of several batches of Lisinopril 5mg breakable tablets, which may lead to a risk of overdose. "The inscription on the aluminium blister pack may be confusing, as it suggests that several tablets should be taken on certain days (...) There is therefore a risk of patients taking too many tablets," they wrote. According to the ANSM, risks in the event of an overdose include fatigue, balance problems, hypotension, and impaired kidney function. A total of four batches of Lisinopril 5mg, or 32,640 boxes, are being recalled. These are batch number 8172295 (28 tablets expiring in January 2026), 8189879 (28 tablets expiring in March 2027), 8172296 (84 tablets expiring in January 2026) and 8192737 (84 tablets expiring in March 2027). Patients are asked to return affected boxes to their pharmacy. Advertisement ANSM also said 'the quality of the tablets [in the affected batches] is not in question'. The recall was solely to prevent possible overdoses prompted by the misprinted packaging. If you are concerned your medication could be affected by a recall, you can always take it to your local pharmacy and ask the pharmacist for their advice. READ MORE: How you can check for food contamination warnings in France
Local France
11-12-2024
- Local France
What changes for healthcare in France in 2025
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Local France
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- Local France
French drug safety agency seeks to ban over-counter cold remedy sales
The Agence Nationale de Sécurité du Médicament (ANSM) has long said that cold-and-flu remedies such as decongestants or combined decongestants and painkillers in tablet or spray form have rare but potentially serious side effects, including heart failure or stroke. Last year, after several warnings over previous winters, the ANSM specifically advised people against buying common cold treatments including well-known brands such as Actifed, Dolirhume, Rhinadvil, or Humex because they all contain pseudoephedrine, which narrows blood vessels and may pose a cardiovascular risk – especially to vulnerable people. Now, with the heavy cold season again looming large on the horizon, the drug safety agency has reissued its warning and has said that it is considering 'listing' these drugs – a measure that would take effect immediately and would effectively result in them no longer being available for sale over-the-counter in pharmacies across France. 'Dispensing these drugs without a medical prescription no longer appears appropriate,' it said in an email to AFP. Dr Jean-Paul Hamon, honorary president of the Fédération des médecins de France (FMF), told Franceinfo that, though rare, the risk to long-term health posed by the remedies was a price not worth paying just for an unblocked nose. Instead, he recommended taking paracetamol for any headaches and using a saline solution to clear nostrils. 'A well-treated cold lasts seven days and an untreated one lasts a week,' he added. Last year, the European Medicines Agency imposed additional contra-indications on cold medicines that contain pseudoephedrine after an investigation prompted by the ANSM, but decided that the risk posed was insufficient to ban them outright. As a result health authorities in France cannot order their complete withdrawal here, but can require they are available only with a prescription.
