Key takeaways:
In 2020, the FDA issued a recall of all versions of a heartburn medication called ranitidine, better known as Zantac, due to a potential cancer risk.
In 2021, Zantac relaunched with a new name and different active ingredient — Zantac 360 (famotidine). Famotidine doesn't have the same cancer risk as traditional ranitidine, making it a safer option.
The FDA approved a reformulated prescription-only version of ranitidine in late 2025. It was tested to ensure it doesn’t form detectable N-nitrosodimethylamine (NDMA) under recommended storage conditions.
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In April 2020, the FDA issued a recall of all prescription and over-the-counter (OTC) versions of ranitidine, the generic name of Zantac. Although the FDA began investigating and recalling certain manufacturers of ranitidine, this announcement called for all retailers to completely clean their shelves of the product, regardless of which company produced it. This left many people wondering why and if they would ever see the medication return.
In mid-2021, Zantac returned to pharmacy shelves as an OTC product. But if you read the package closely, you’ll find that Zantac 360 is not the same as the original. And, in late 2025, the FDA approved a reformulated prescription version of ranitidine. So what’s the difference between the original and reformulated products?
In this article, we’ll discuss what Zantac 360 is, why the original Zantac was recalled, and what you can expect from the new versions.
What was Zantac? Understanding the original ranitidine medication
Zantac was the original brand name for ranitidine, an OTC medication that treated and prevented heartburn and acid reflux. At higher prescription-only doses, it was also used to treat stomach ulcers and erosive esophagitis (when the tube that connects your mouth and stomach is damaged by stomach acid).
Unlike proton pump inhibitors (PPIs), such as omeprazole (Prilosec) and lansoprazole (Prevacid), which can take several days to kick in and lessen symptoms, Zantac typically started relieving heartburn within 15 to 60 minutes after it was taken. It continued working for up to 12 hours, compared to traditional antacids like Tums and Mylanta that tend to wear off within a half-hour.
These qualities made Zantac a great choice for people who have occasional heartburn or know they’re likely to experience it soon. Zantac was taken off the market due to potential cancer risks, not because it was ineffective. More on this below.
What is Zantac 360, and how does it differ from original Zantac?
Zantac 360 is an oral tablet containing the active ingredient famotidine. It comes in two different doses (10 mg and 20 mg) and is available without a prescription. The OTC tablets are only recommended for adults and children over 12 years old.
If the word famotidine looks familiar, that’s because it is also the active ingredient in brand name Pepcid AC, another OTC heartburn remedy. The famotidine in these competing products is the same. Both provide the same symptom relief, and neither has any advantages over the other.
Unlike the original version of Zantac, Zantac 360 does not contain ranitidine. They work the same way, though, and are similarly effective for heartburn and acid reflux.
Famotidine and ranitidine both belong to a class of medications called histamine-2 antagonists (H2 blockers). They work by blocking the acid-producing cells in the stomach. Think of it like plugging up a hole that’s leaking water. The only other H2 blockers currently on the market are cimetidine (Tagamet HB) and nizatadine.
Zantac 360 dosage tip: If you’re actively experiencing heartburn, you can take 1 tablet of Zantac 360 by mouth. To prevent heartburn, on the other hand, take 1 tablet by mouth 15 to 60 minutes before the drink or food that typically causes your acid reflux symptoms.
When and why: Zantac recall timeline
In 2018, the FDA started releasing warnings that various medications contained a chemical called N-nitrosodimethylamine (NDMA). The biggest concern with NDMA is that it’s a potential carcinogen, meaning it may raise your risk of developing cancer.
A year later, a pharmacy named Valisure discovered ranitidine contained much higher levels of NDMA than what is considered safe. They submitted these findings to the FDA.
After investigating, the FDA discovered that NDMA levels in ranitidine could increase over time and when stored at higher temperatures — including temperatures the medication might reach during shipping or storage. Because of this instability, the FDA requested in April 2020 that all prescription and OTC ranitidine products be removed from the market.
At the time of the recall, the main concern was the potential long-term cancer risk from elevated NDMA exposure — not an immediate safety issue.
Since then, some observational studies have reported higher rates of certain cancers — including breast, thyroid, and testicular cancers — among people who regularly used ranitidine compared with those who used other heartburn medications. Research is still ongoing.
In the years following the recall, manufacturers have worked on reformulating ranitidine to prevent NDMA formation. And in November 2025, the FDA approved a new prescription-only version of ranitidine. It was extensively tested to make sure it doesn’t form detectable NDMA when stored as directed. It’s available as 150 mg and 300 mg tablets. OTC ranitidine products haven’t returned to the market.
Good to know: Small amounts of NDMA can be found in food, water, and naturally in the environment. Our bodies can break down small amounts of this chemical without problems. But being exposed to too much over time can be harmful.
What are the side effects of Zantac 360?
Zantac 360 is tolerated very well, and most people have no side effects after taking a dose. In clinical studies of famotidine, only a small number of participants reported headache, dizziness, or constipation.
Some serious but less common side effects may include:
Fever
Palpitations (feeling like your heart is pounding or fluttering)
Elevated liver enzymes
Hallucinations
Rash
Trouble sleeping
If you’re experiencing anything unusual after starting this medication, contact your healthcare team to discuss alternatives.
Other Zantac 360 precautions
To be safe, talk with a healthcare professional before taking Zantac 360. Heartburn symptoms can sometimes be similar to those of more serious problems, such as stomach cancer. Using Zantac 360 could mask those symptoms or prevent you from seeking the proper medical attention.
Contact your healthcare team if you have any of the following symptoms:
Heartburn for more than 3 months
Pain that is causing swallowing difficulties
Nausea or vomiting with or without blood
Stomach pain
Unexplained weight loss
Zantac 360 is also linked to brain-related effects, such as:
Agitation
Confusion
Disorientation
Hallucinations
Seizures
Tiredness and low energy
Adults over 65 and people with kidney problems might have a higher risk for these brain-related effects. If you experience these side effects, stop taking Zantac 360, immediately notify your healthcare team, and seek emergency medical attention.
If you had a previous allergic reaction to ranitidine, famotidine, or other H2 blockers, don’t take famotidine, either.
How to save on Zantac 360
There are ways to save on Zantac 360, which is available OTC as both a brand-name and generic medication. GoodRx can help you save over 40% off the average retail price of the generic version.
With a prescription from a healthcare professional, 60 tablets of generic Zantac 360 may cost as little as $12.79 with a free GoodRx discount at certain pharmacies.
Keep in mind that your GoodRx coupon may include the name Pepcid AC on it. But it can be applied to any OTC version of famotidine, including generic Zantac 360.
Frequently asked questions
No, Zantac and Zantac 360 are H2 blockers — not PPIs. H2 blockers reduce stomach acid by blocking histamine receptors in the stomach. PPIs, such as Prilosec and Nexium, work differently. They typically provide longer-lasting acid suppression, but they may take longer to start working.
Zantac 360 is generally considered low risk during pregnancy and hasn’t been linked to birth defects in available studies. Still, you should talk to your prenatal care team before taking it to make sure it’s the right choice for you. Medications like Tums (calcium carbonate) may be a safer choice during pregnancy.
No, Zantac and Zantac 360 are H2 blockers — not PPIs. H2 blockers reduce stomach acid by blocking histamine receptors in the stomach. PPIs, such as Prilosec and Nexium, work differently. They typically provide longer-lasting acid suppression, but they may take longer to start working.
Zantac 360 is generally considered low risk during pregnancy and hasn’t been linked to birth defects in available studies. Still, you should talk to your prenatal care team before taking it to make sure it’s the right choice for you. Medications like Tums (calcium carbonate) may be a safer choice during pregnancy.
The bottom line
Due to concerns related to N-nitrosodimethylamine (NDMA), all forms of ranitidine were removed from the market in 2020, including the original version of Zantac. Zantac has since returned to pharmacy shelves as Zantac 360, which contains famotidine instead of ranitidine. Zantac 360 provides similar heartburn relief without the NDMA concerns linked to the original product. A new prescription-only version of ranitidine has also been FDA approved and tested to ensure it doesn’t form detectable NDMA when stored as directed.
Why trust our experts?
References
Adamson, R. H., et al. (2020). The finding of N‐nitrosodimethylamine in common medicines. Oncologist.
American Cancer Society. (2026). Signs and symptoms of stomach cancer.
American Chemical Society. (2019). N-nitrosodimethylamine.
Ernst, D. (2025). FDA clears reformulated ranitidine with updated storage rules.
Tougas, G., et al. (1997). Efficacy of H2 receptor antagonists in the treatment of gastroesophageal reflux disease and its symptoms. Canadian Journal of Gastroenterology and Hepatology.
U.S. Food and Drug Administration. (2020). FDA requests removal of all ranitidine products (Zantac) from the market.
U.S. Food and Drug Administration. (2024). Information about nitrosamine impurities in medications.
U.S. Food and Drug Administration. (2025). FDA approves reformulated ranitidine following comprehensive safety review.
Valisure. (2019). Valisure detects NDMA in ranitidine.
XLCare Pharmaceuticals. (2021). FAMOTIDINE- famotidine tablet, film coated [package insert].
