Fda Voluntary

On September 23, 2019, the FDA announced a voluntary recall of all lots of prescription ranitidine capsules. These acid-blocking medications are used to treat conditions such as ulcers, acid reflux, and esophagitis. Unfortunately, tests have revealed they may contain unacceptable levels of the contaminant N-Nitrosodimethylamine (NDMA). NDMA is a substance which may cause cancer in humans. Ranitidine, also known by the brand name Zantac, is also available over the counter for treating heartburn, acid reflux, and sour stomach.

5. What Is NDMA?


Once a component of rocket fuel, United States manufacturers no long intentionally produce NDMA. According to the EPA, NDMA may be an unintended byproduct of chemical reactions in the course of synthesizing other products. Furthermore, NDMA is found in air, the water supply, and food products. The FDA maintains guidelines for the maximum allowable levels of this contaminant in food and medications.

4. The Discovery of Ranitidine Contamination

Ranitidine Contamination

According to Medscape Pharmacists, the first inkling of a possible impurity in ranitidine tablets came to light in June 2019. At that time, Swissmedic, the Swiss Health Authority, found traces of NDMA in Sandoz-manufactured ranitidine tablets. These levels were above those allowed by health authorities. Further testing prompted Sandoz to voluntarily recall certain lots of ranitidine hydrochloride capsules in both the 150mg and 300mg strengths. You can find the NDC and lot numbers for the recalled capsules on the Sandoz website.

Related: Acid Reflux Drug Linked to More Than Doubled Risk of Stomach Cancer

3. Steps to Take if You Use Ranitidine

Use Ranitidine

According to the FDA website, individuals who take ranitidine should follow the recall instructions provided by Sandoz. The FDA states that while they investigate the contamination, patients can continue to take ranitidine from lots not included in the recall. Not all ranitidine products are included in this recall. Therefore, patients who rely on this medication can continue to find this drug. Those who would prefer to switch to a different type of acid blocker can contact their doctors for a recommendation.

2. What Is a Voluntary Recall?

Drug Recall

When a drug manufacturer voluntarily decides to remove a drug product from the market due to concerns regarding safety or effectiveness, it is known as a recall. The FDA lists three classifications of recalls. First, Class I refers to a dangerous or defective product that may cause severe health issues or death. Next, Class II represents products that may cause a temporary health problem or pose a slight threat of a serious nature. Finally, Class III recalls are for products that are unlikely to cause adverse health reactions, but that violate labeling or manufacturing laws.

1. Other Drugs Tainted by NDMA

Ranitidine Medication

Ranitidine is not the first medication to test at unacceptable levels for NDMA. Earlier this year, pharmaceutical companies recalled certain lots of three blood pressure medications. The drugs involved are losartan, valsartan, and irbesartan. These medications are angiotensin II receptor blockers (ARBs). ARBs lower blood pressure through their effects on blood vessels. The FDA warns consumers not to discontinue taking their blood pressure medications without the supervision of a physician. So far, there have been no reports of NDMA-related injury to patients taking these medications.

Related: 10 Foods That Help Decrease Acid Reflux


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