Sandoz Inc. has announced a voluntary recall for generic Zantac (ranitidine) heartburn medications because they may be contaminated by a cancer-causing chemical called N-nitrosodimethylamine (NDMA).
No recalls have been issued for brand-name Zantac® yet.
The contamination was first discovered by Valisure, an online pharmacy that routinely tests medicines it buys before re-selling them to consumers.
Valisure reported that their tests “detected extremely high levels” of NDMA in every lot of ranitidine that it tested, including batches made by different manufacturers and different dosages.
Valisure has submitted a citizen petition demanding that the FDA recall all medicines that are contaminated by NDMA.
The FDA is currently testing brand-name Zantac® and generic ranitidine from multiple manufacturers and assessing the possible risk.
In the meantime, the agency believes the levels of NDMA in ranitidine “barely exceed amounts you might expect to find in common foods.”
Source: FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity