Ranitidine is back on the US market after a five-year absence. The FDA has approved a reformulated version of the drug, once known as Zantac, following major manufacturing changes and new safety testing.
But the agency’s announcement left one critical question unanswered: Has NDMA—the carcinogen that triggered the 2020 market removal—been fully eliminated?
Ranitidine was a blockbuster heartburn medication used for GERD, ulcers, and Zollinger-Ellison syndrome. It was first approved in 1983 and became one of the industry’s earliest billion-dollar drugs.
The collapse began in 2019, when Zhejiang Huahai Pharmaceuticals detected NDMA, a probable carcinogen, in ranitidine samples.
Further testing showed something far worse:
NDMA levels increased over time, especially in warm storage conditions, making the product riskier the longer it sat on shelves.
By April 2020, the FDA requested complete market withdrawal.
The FDA confirmed that the manufacturer has completed extensive safety testing and introduced improved manufacturing controls. However, the agency did not explicitly confirm the complete removal of NDMA.
The approval email instead highlighted updated handling requirements designed to reduce potential risks.
The FDA now requires:
Pharmacists are encouraged to walk patients through these instructions.
Patients already using another H2 blocker or a proton pump inhibitor should check with their clinician before switching.
Before its downfall, ranitidine dominated the acid-reflux market. By 1987, it had already surpassed $1 billion in annual sales, making it a global blockbuster.
After NDMA alarms surfaced, regulators worldwide conducted investigations. Retailers and manufacturers began halting sales in September 2019, even before the FDA’s official market removal the following year.
The reformulation marks ranitidine’s first major comeback attempt since then.
Ranitidine’s return may create more options for heartburn and GERD management, especially for people who struggled with alternatives.
But the lack of explicit NDMA confirmation means many clinicians will stay cautious.
The updated handling rules suggest that storage stability remains a key concern, even with the reformulated product.