Why Is Ranitidine No Longer Used? The Recall of a Common Heartburn Medication

October 8, 2025 •

4 min read

In a major 2020 safety announcement, the U.S. Food and Drug Administration (FDA) requested the immediate market withdrawal of all prescription and over-the-counter ranitidine products, which were commonly known by the brand name Zantac. This action left millions of consumers wondering why is ranitidine no longer used and what prompted the removal of one of the world's best-selling drugs from pharmacy shelves. The withdrawal was prompted by findings of a potential cancer-causing impurity called N-Nitrosodimethylamine (NDMA) in the medication.

Quick Summary

Ranitidine, a popular heartburn drug, was recalled by the FDA in 2020 due to unacceptable and increasing levels of a probable carcinogen, NDMA, found in the medication. This action was taken to protect public health and led to the removal of all ranitidine products from the market.

Key Points

NDMA Contamination: The key reason for the recall was the discovery of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, in ranitidine products.
Drug Instability: NDMA levels in ranitidine could increase significantly over time and when exposed to higher temperatures, posing an unacceptable health risk.
Precautionary Recall: The U.S. FDA requested the immediate and full market withdrawal of all ranitidine products (including brand-name Zantac) in April 2020 to protect public health.
Safe Alternatives Available: A number of safe and effective alternatives exist, including other H2 blockers (famotidine, cimetidine) and Proton Pump Inhibitors (PPIs) like omeprazole.
New Zantac Formulation: The brand Zantac was reformulated and relaunched as Zantac 360, with famotidine as its new, NDMA-free active ingredient.
No Immediate Risk from Past Use: Health advisories indicate that low-level exposure to NDMA is common and unlikely to cause harm, but the recall addressed the risk of sustained, long-term exposure to higher levels.
Ongoing Legal Action: Numerous lawsuits have been filed against ranitidine manufacturers, claiming the drug led to various types of cancer.

The Discovery of a Carcinogenic Impurity

For decades, ranitidine was a cornerstone of treatment for acid-related conditions, prized for its effectiveness in treating heartburn and gastric ulcers. As a histamine-2 (H2) blocker, it worked by reducing the amount of acid produced by the stomach. However, in 2019, an independent laboratory, Valisure, detected concerning levels of N-Nitrosodimethylamine, or NDMA, in ranitidine products and petitioned the FDA for a recall. This discovery prompted an extensive investigation by global health authorities, including the FDA.

What is NDMA?

NDMA is classified as a probable human carcinogen based on laboratory tests, meaning it could potentially cause cancer. It is also a common environmental contaminant found at low levels in various foods, water, and cigarette smoke. While low-level ingestion is normal and generally not harmful, sustained exposure to higher levels may increase cancer risk. The primary concern with ranitidine was not just the presence of NDMA but the finding that its levels could rise significantly under certain conditions.

Ranitidine's Instability and NDMA Formation

Initial FDA testing showed low NDMA levels in ranitidine, but later tests revealed that these levels could increase over time and when stored at temperatures above room temperature. This instability was linked to the chemical structure of the ranitidine molecule. Unlike NDMA contamination in some other medications, the issue with ranitidine appeared to be caused by the drug's inherent breakdown, meaning that even products with safe NDMA levels when manufactured could develop unsafe levels by the time they were used by patients.

The Recall Timeline

The withdrawal of ranitidine products occurred in phases:

September 2019: The FDA alerted the public about NDMA in ranitidine. Some companies issued voluntary recalls.
April 1, 2020: The FDA requested the immediate withdrawal of all ranitidine products from the U.S. market.
April 2020 and beyond: Other international regulators also suspended or withdrew ranitidine.

Alternatives to Ranitidine

For those who previously used ranitidine, safe alternatives are available, including other H2 blockers and Proton Pump Inhibitors (PPIs). The FDA has tested other H2 blockers like famotidine and found no NDMA contamination. Zantac has also been relaunched as Zantac 360, using famotidine as its active ingredient.

Comparison of Ranitidine vs. Common Alternatives


Feature	Ranitidine (Original Zantac)	Famotidine (Pepcid, New Zantac 360)	Omeprazole (Prilosec)	Cimetidine (Tagamet)
Drug Class	H2 Blocker	H2 Blocker	Proton Pump Inhibitor (PPI)	H2 Blocker
NDMA Risk	High; potential for increasing levels over time and with heat	None found in FDA testing	None found in FDA testing	None found in FDA testing
Availability	Recalled; No longer available	Available OTC and by prescription	Available OTC and by prescription	Available OTC and by prescription
Mechanism	Decreases stomach acid by blocking H2 receptors	Decreases stomach acid by blocking H2 receptors	Permanently blocks an enzyme responsible for acid production	Decreases stomach acid by blocking H2 receptors
Potency	Standard effectiveness; superseded by PPIs in efficacy	Can be more potent than ranitidine in reducing stomach acid	More effective at reducing stomach acid than H2 blockers	Less potent than ranitidine

Potential Health Concerns and Ongoing Litigation

The FDA's withdrawal request was based on the potential for unacceptable NDMA levels and a possible increased cancer risk over a long period. The exact risk for individual patients was not fully established. This uncertainty has resulted in numerous lawsuits against manufacturers of ranitidine and Zantac, with plaintiffs claiming a link between the drug and various cancers.

Ongoing studies and litigation are examining the possible connections between ranitidine and cancers like bladder, stomach, and liver cancer. Since direct clinical trials on potential carcinogens are not feasible, evidence comes from observational studies, which have shown mixed results and limitations in accurately measuring patient NDMA exposure. The legal situation is complex but underscores the necessity of continuous drug safety monitoring.

Conclusion

The primary reason why is ranitidine no longer used is the discovery of NDMA, an unstable chemical compound in the medication that could reach potentially harmful levels over time. The FDA's 2020 action to request the removal of all ranitidine products was a precautionary step to safeguard public health, prompted by evolving scientific understanding of drug stability and NDMA risks. While ranitidine is no longer available, numerous safe and effective alternative treatments for acid reflux and related conditions exist. Consulting a healthcare professional is always recommended for personalized treatment advice. For those concerned about past use, public health advisories generally suggest that the risk from low-level exposure is likely minimal, but ongoing research and legal cases highlight the serious safety concern that led to the recall.

Authoritative Outbound Link: For the latest information on drug safety from the FDA, you can visit their official updates page: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine.

Frequently Asked Questions

According to the FDA, low levels of NDMA are common in foods and water and are not expected to cause harm. The recall was based on the risk of long-term exposure to potentially unacceptable levels. If you are concerned about past use, you should consult with your healthcare provider.

Safe and effective alternatives include other H2 blockers like famotidine (Pepcid, Zantac 360) and cimetidine (Tagamet), as well as Proton Pump Inhibitors (PPIs) like omeprazole (Prilosec) and esomeprazole (Nexium).

The original Zantac contained ranitidine, which has been recalled due to NDMA contamination. Zantac 360 is a reformulated product that uses famotidine as its active ingredient, which has not been found to have NDMA contamination.

The FDA advises that you can dispose of unused ranitidine products by taking them to a drug take-back site. If one is not available, you can mix the medication with an unappealing substance like dirt or used coffee grounds, put it in a sealed container, and throw it in the household trash.

The FDA has tested other heartburn medications, including famotidine and PPIs, and has not found similar NDMA contamination in them. NDMA was also previously found in some batches of blood pressure medications called ARBs, but this was due to different manufacturing issues.

While NDMA is a probable carcinogen and some studies have investigated links to various cancers, including stomach cancer, the results of human observational studies have been mixed and often limited by design factors. Long-term studies are difficult, and legal actions are ongoing.

The FDA has set the acceptable daily intake limit for NDMA at 96 nanograms per day. This amount is considered reasonably safe for daily ingestion over a 70-year lifespan. Ranitidine was found to potentially break down into levels of NDMA that exceeded this limit.