The recall affects medications sold in the United States and Canada. Sanofi is working with the US Food and Drug Administration to determine the extent of the recall.
Tests of Zantac and other ranitidine drugs found NDMA, a contaminant that is considered a possible carcinogen by the US Environmental Protection Agency, said the FDA and Health Canada in September. NDMA may inadvertently be introduced into production through certain chemical reactions.
The FDA has tested several drugs after it found impurities in medicines for blood pressure and heart failure, known as ARBs.
Walmart, CVS Pharmacyjor and Walgreens recently They would stop selling ranitidine medicines because of concerns they might contain the impurity. In September, drug manufacturer Novartis said it stopped distribution of all ranitidine drugs made by Sandoz.
Sanofi said it gave the recall after discrepancies in preliminary test results. The investigation is ongoing and Sanofi said it would share the results of its tests with the FDA and Health Canada.
Sanofi urged patients using Zantac OTC to reach out to their doctors and pharmacists with questions about treatment going forward.
The FDA has stated that it is cooperating with international regulators and the industry to determine the source of the impurity. The agency said it was not asking patients to stop taking the medication, but also advised to speak with a physician to stop treatment.