FDA Calls for Withdrawal of All Ranitidine Products

The FDA called for the immediate withdrawal of all ranitidine products from the market due to N-Nitrosodimethylamine (NDMA) contamination.

The agency’s research has shown that the impurity increases over time when stored at higher than room temperatures and may result in exposure to higher levels of the impurity

“Since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said CDER Director Janet Woodcock.