A Reputation Built By Success

Major Zantac recalls over high levels of potential carcinogen

Zantac is a popular over-the-counter medication used to treat heartburn. Its generic name is ranitidine, and it has been available since 1981 as a prescription medication. In fact, it was so wildly successful that it was the best-selling prescription by 1987. Eventually, demand for the drug combined with low risk led to its availability as an over-the-counter medication.

There are hundreds of thousands of people who take Zantac either at their own discretion or under the recommendation of their physician. Anyone who takes Zantac or its generic equivalent ranitidine should familiarize themselves with the current voluntary recall announced by the Food and Drug Administration that has been ongoing since late 2019.

Contaminated medication tested positive for a dangerous substance

Certain chemical compounds used in the manufacturing of medications are safe in low doses but dangerous at higher levels. N-nitrosodimethylamine (NDMA) is one such chemical. The FDA has a strict limit of 96 nanograms per day or 0.32 parts per million for the amount of NDMA that can exist in any medication.

Recent tested batches of various formulations of ranitidine have exceeded the FDA limit for NDMA, prompting the recalls. There are a number of generic medications, over-the-counter drugs and prescription medications involved in these recalls. Anyone who takes ranitidine or Zantac regularly should check their medication to see if it is part of any of these recalls.

The issue with high levels of NDMA

Why would the FDA order the recall of popular medications over an increase in a substance they already know is present in that medication? The answer is simple. Most times, the poison is in the dose, as the saying goes.

Taking a medication with high levels of a known carcinogen for a long amount of time could result in eventually developing a cancer you otherwise would not have. Those who take the medication without inappropriate levels of NDMA likely won’t have any increased risk because of the lower and safer level of NDMA present.

Failing to ensure that there isn’t a dangerous level of a potential carcinogen in a drug is a major oversight on the part of the manufacturer. People who become sick because of defective medication or who get hurt because of defective products have the right to hold manufacturers accountable for their inadequate oversight, improper quality control or corner-cutting when it comes to consumer safety.