USA, December 2, 2025: After a five-year absence from pharmacy shelves, ranitidine tablets have received FDA approval to return to the U.S. market. The reformulated medication addresses the safety concerns that led to its removal in 2020, though some healthcare experts are urging caution before widespread adoption.
On November 24, 2025, the U.S. Food and Drug Administration approved reformulated ranitidine tablets, marking a significant development in gastroesophageal treatment options. The medication commonly known by its former brand name Zantac was pulled from the market in April 2020 due to contamination concerns.
“Ranitidine, an H2 receptor antagonist, is widely used to treat conditions including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome,” according to the FDA.
Dr. Ethan Melillo shared his perspective on the news through an Instagram (@millennialrx) reel. “We have some huge pharmacy news because ranitidine, which is used for heartburn, is coming back," he noted. "We are getting back the 150 and the 300 milligram strengths."
The original formulation was withdrawn after testing revealed the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen. FDA findings indicated that the contaminant could form when the medication was stored at temperatures higher than room temperature.
The newly approved ranitidine has undergone extensive safety testing and manufacturing improvements designed specifically to prevent NDMA formation during the product’s shelf life. However, the new formulation comes with strict storage requirements that differ significantly from the original product.
Healthcare providers and patients must adhere to the following guidelines by FDA:
Keep tablets in the original container and protect from moisture.
Discard unused tablets 90 days after first opening the bottle or by the expiration date, whichever comes first.
Open only one bottle at a time if multiple bottles are dispensed
Remove one tablet at dosing time and immediately resecure the cap.
Keep the desiccant in the bottle at all times.
During ranitidine’s absence, the pharmaceutical landscape adapted significantly. As Dr. Melillo explained, “After ranitidine was removed from the market, Zantac rebranded themselves to Zantac 360, but the ingredient is different.” The reformulated Zantac 360 contains famotidine, the generic version of Pepcid, another H2 receptor antagonist that was not affected by NDMA concerns.
This market shift has influenced some healthcare providers’ views on ranitidine’s return. “In my opinion, they should have renamed it Zantac 180 because they had to do a whole 180 when it came to their marketing, because all they did was change the ingredient to famotidine,” Dr. Melillo remarked.
While FDA approval indicates that the reformulated ranitidine meets current safety standards, some healthcare professionals remain hesitant to immediately recommend it. Dr. Melillo expressed a wait-and-see approach: “This is going to give patients more options. Personally though, with this news, I still probably wouldn’t be recommending myself or anyone take this yet.”
His reasoning reflects a pragmatic clinical perspective. “I'm sure the medication is probably fine, but when you have something like Pepcid that works the same, has been on the market, and hasn’t had any of these recalls, you might as well just go with what’s been working,” he explained.
(Rh/VK/MSM)