The FDA is asking all drugmakers to pull ranitidine products from the shelves after finding "unacceptable levels" of a possible carcinogen can develop in the products over time.
The FDA began investigating the presence of N-Nitrosodimethylamine, or NDMA, in ranitidine products last September after Valisure, an online pharmacy, found NDMA while testing the quality of the drug and filed a citizen's petition asking the FDA to recall them.
Ranitidine products are popular heartburn drugs commonly sold under the brand name Zantac.
NDMA is an organic chemical that was once used to make rocket fuel and is an unintended byproduct of certain chemical reactions, according to Stat.
After months of investigating, the FDA found that levels of NDMA may gradually increase in ranitidine products over time and can increase significantly if stored above room temperature.
Ranitidine products will no longer be available in the U.S. for new or existing prescriptions or for over-the-counter use. The FDA advised anyone taking over-the-counter ranitidine to stop taking it, dispose of the drugs and not buy more. The agency said other over-the-counter drugs can be used to treat heartburn.
Patients taking prescription-strength ranitidine should talk to their healthcare providers about alternative treatments before stopping use, the FDA said.
Read the full news release here.