FDA Approves Reformulated Ranitidine After 5-Year Absence

The FDA has approved a reformulated version of ranitidine (VKT Pharma), a once-popular heartburn medication, after a 5-year suspension from the US market after it was found to contain a probable human carcinogen in 2020.^1,2

The news, released via email, did not address whether the carcinogen N-nitrosodimethylamine (NDMA) had been completely removed from ranitidine, but it did state that the manufacturer conducted "extensive safety testing and manufacturing improvements that address previous concerns."¹ VKT Pharma's website did not specify what changes were made to the formulation, or make any reference to the new approval other than to list ranitidine among its approved products.³

Ranitidine is an H₂ receptor antagonist which, along with its generic and over-the-counter competitors, was used to treat patients with various gastroesophageal conditions including heartburn, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome.⁵

The FDA first announced the finding of NDMA in ranitidine in September 2019. A series of testing and voluntary recalls followed until April 2020, when the FDA requested the removal of ranitidine from the US market.⁶

The History of Ranitidine

Ranitidine was originally developed by Glaxo Holdings Ltd, now a part of GlaxoSmithKline PLC, and was approved in 1983 in the US as a prescription treatment. By the time its US patent expired in 1987, it had become "one of the first-ever drugs to top $1 billion USD in annual sales," according to Reuters.⁵

Zhejiang Huahai Pharmaceuticals, was the first to detect NDMA in ranitidine-containing drug samples in July 2018. Regulatory agencies around the world announced reviews of ranitidine's safety, and both retail distributors and manufacturers of generic ranitidine began halting distribution in September 2019.^5,6,8

Testing results showed that NDMA levels in ranitidine products increased over time under normal storage conditions, making the products more likely to be carcinogenic the longer they were kept on shelves and in medicine cabinets. Higher levels were also found in products stored at higher temperatures.⁴

New Requirements for Ranitidine

The FDA included new storage guidelines for ranitidine, though they do not, on their face, address whether NDMA has been completely removed from the new formulation. The guidelines are fairly standard across other medications:¹

• Tablets, along with the desiccant, should be kept in the original bottle and kept away from moisture.
• Unused tablets should be discarded after 90 days from opening the bottle or by the expiration date, whichever comes first.
• Bottles should be securely and tightly closed immediately after pill retrieval.

Pharmacists should advise patients on the importance of following all guidelines for ranitidine and other medications. If a patient is currently using another H₂ receptor blocker or a proton pump inhibitor, they should consult their healthcare provider before making any change.

REFERENCES

1. FDA. FDA Approves Reformulated Ranitidine [Internet]. Silver Spring (MD): U.S. Food & Drug Administration; 2025 Nov 25 [cited 2025 Nov 25]. https://content.govdelivery.com/accounts/USFDA/bulletins/3fcf8c1

2. Wighton K. FDA Approves Reformulated Ranitidine After 5 Years. Conexiant. November 25, 2025. https://conexiant.com/gastroenterology/articles/fda-approves-reformulated-ranitidine-after-5-years/

3. VKT Pharma. Products. Published 2019. Accessed November 25, 2025. https://vktpharma.com/products/

4. Drugs.com. Ranitidine: Uses, Dosage, Side Effects, Warnings [Internet]. Cerner Multum, Inc.; updated August 26, 2024. Accessed November 25, 2025. https://www.drugs.com/ranitidine.html

5. Reuters. Timeline: Popular heartburn medicine Zantac pulled off store shelves. Reuters. October 21, 2019. Accessed November 25, 2025. https://www.reuters.com/article/business/healthcare-pharmaceuticals/timeline-popular-heartburn-medicine-zantac-pulled-off-store-shelves-idUSKBN1X014D/

6. FDA. FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Updated April 16, 2020. Accessed November 25, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine

7. Ernst, D. FDA Clears Reformulated Ranitidine With Updated Storage Rules. Medical Professionals Reference. November 25, 2025. Accessed November 25, 2025.

8. U.S. Food and Drug Administration. Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac). FDA. Updated April 1, 2020. Accessed November 25, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac