110,000 boxes of amoxicillin recalled throughout France due to the presence of a large quantity of “a non-pathogenic bacteria”

The French National Agency for the Safety of Medicines announced this Tuesday, August 20, 2024, the recall of four batches of amoxicillin, the most widely used antibiotic in France, due to the presence “in quantities higher than the authorized standard of a non-pathogenic bacteria”.

The National Medicines Safety Agency (Ansm) published a press release this Tuesday, August 20, 2024 announcing the recall of four batches of amoxicillin, the ’most used"antibiotic. quot; in France.

This recall concerns three batches marketed by Teva Santé laboratories and one batch by Sandoz. This decision follows the discovery of non-compliant microbiological results during batch stability control, revealing the presence of Bacillus subtilis beyond authorized standards.

No risk to human health

According to the Ansm, there is no significant risk for human health. The Bacillus subtilis bacteria, although detected in higher than normal quantities, is generally not dangerous for humans, except in rare cases of food poisoning. The health authority also stressed that this recall will not affect the availability of amoxicillin 1 g on the market, while tensions over antibiotics are recurrent.

According to BFMTV, Approximately 110 000 boxes of the drug are affected by this recall, distributed throughout France via wholesalers. The Ansm indicated that pharmacists with these batches must return them to their suppliers. However, no recall is planned for individuals, because the batches in question have been distributed for a long time, and it is unlikely that patients still have them in their possession.

The batches concerned

The Teva Santé and Sandoz laboratories, at the origin of the defective batches, are carrying out investigations to understand the causes of this defect and prevent it from recurring. They also clarified that no reports of quality issues regarding these batches have been reported since their distribution in 2023 and 2024.

The lots of amoxicillin affected by this recall are as follows: Amoxicillin Teva Santé 1 g dispersible tablet (lots MT2985, MS8574 and MS8584) and Amoxicillin Sandoz 1  g dispersible tablet (lot MR8824).