FDA

FDA OKs reformulated ranitidine 5 years after pulling the drug from the market

November 25, 2025

On November 24, 2025, FDA approved reformulated ranitidine tablets (VKT Pharma), marking the return of the acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about the formation of N-nitrosodimethylamine (NDMA)—a probable human carcinogen—during the product’s shelf-life.

Ranitidine, an H2 receptor antagonist, is indicated for the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

According to an FDA press release, HCPs and patients should be aware that the reformulated ranitidine maintains the same therapeutic effectiveness as previously approved products. Patients currently using alternative H2 blockers or proton pump inhibitors should consult their HCPs before switching medications. Approved products will include updated labeling with storage and handling instructions. Patients and HCPs should consider the new storage conditions for the safe and effective use of the product, including:

• Keep ranitidine tablets in the original container (bottle) and protect from moisture.
• After the first opening of the bottle, discard unused tablets after 3 months (90 days), or by the expiration date on the bottle, whichever is sooner.
• If more than one bottle is dispensed, open only one bottle at a time. Store additional bottles without opening until needed for dosing.
• At the time of dosing, remove one tablet from the bottle. Immediately close the bottle, secure the cap, and keep the bottle tightly closed.
• Keep the desiccant in the bottle.

Source:

FDA approves reformulated ranitidine following comprehensive safety review. [News release]. 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-reformulated-ranitidine-following-comprehensive-safety-review