Medicine safety alert - ranitidine (withdrawn)

Ranitidine products (Brand names including Zantac®) were voluntarily withdrawn by manufacturers in October 2019 due to the presence of low levels of an impurity called NDMA. The European Medicines Agency has since confirmed its recommendation to suspend all ranitidine medicines in the EU.

This medication is used to treat acid reflux in children and babies. There is currently no information about this product becoming available again, and so members are advised to: 

  1. Attempt deprescribing, unless there are extenuating circumstances (eg previous gastrointestinal bleeds, or severe failure to thrive related to GORD). This is especially true if no current symptoms. 
  2. Consider alternative medications if the patient is not already using them, such as alginates, or escalation of therapy to a proton pump inhibitor. 

As there is no evidence that supply will be restarted in the near future, current treatment protocols that contain ranitidine will also need to be reviewed.


This news page was originally published on 26 June 2020 to note the voluntary withdrawal of this medicine. On 10 February 2021, it was updated to note that the European Medicines Agency has confirmed its recommendation to suspend all ranitidine medicines in the EU.