FDA Citizen Petition #2: NDMA Carcinogen in Ranitidine (Zantac) & Nizatidine (Axid)
Valisure’s routine batch-level testing uncovered a major pharmaceutical safety issue: ranitidine (commonly sold as Zantac) was found to form N-Nitrosodimethylamine (NDMA), a potent carcinogen, due to the inherent instability of the ranitidine molecule itself. This breakthrough finding meant that all brands, generics, and lots of ranitidine were potentially unsafe, regardless of manufacturer or storage conditions.
Valisure filed a comprehensive FDA Citizen Petition urging an immediate market withdrawal of all ranitidine products. The FDA responded by requesting a nationwide recall, and global regulators soon followed. Valisure’s findings, along with research from Stanford University and others, fundamentally shifted scientific understanding of ranitidine’s risks.
This case demonstrated the urgent need for chemical stability testing in quality assurance processes and became one of the most significant pharmaceutical recalls in history.
Full Petition: Read the complete Citizen Petition →
Media Coverage Highlights:
- Bloomberg BusinessWeek | The Big Take: Zantac’s Maker Kept Quiet About Cancer Risks for 40 Years
- Bloomberg BusinessWeek: The Problem with Drug Recalls
- Bloomberg News: Leading Cancer Center No Longer Offering Zantac to Patients
- CBS News Special: Chemical Found in Zantac Raises Concerns
- Dr. Peter Attia Podcast: David Light: Zantac recall due to cancer concerns – what you need to know
- NPR: Pharmacies Pull Zantac Over Concern That Contaminant Poses Cancer Risk
- The Print (India): Explained: Why India US haven’t recalled acidity drug Ranitidine but France & Canada have
- The Washington Post: A tiny pharmacy is identifying big problems with common drugs, including Zantac
- The Daily Mail(UK): Zantac is Pulled from Shelves in the UK
- WebMD: Heartburn Drugs and Cancer: What Are the Risks?
Worldwide Regulatory Response:
Following Valisure’s discovery, countries across the globe recalled or banned ranitidine products in one of the most widespread pharmaceutical actions ever recorded.
Summary of Actions Around the World:
- Australia – Recalled all ranitidine products from pharmacies, hospitals and wholesalers
- Austria – Recalled all ranitidine products
- Bangladesh – Ban on sales of ranitidine
- Bahrain – Suspended the registration, importing, and distribution of all products containing ranitidine
- Canada – Stopped distribution of all ranitidine products/brands. First country to issue a ban.
- Cyprus – Recalled every product containing ranitidine
- Denmark – Recalled ranitidine products from shelves and banned distribution
- Dominican Republic – Ban on all ranitidine products
- Egypt – Ban on distribution and sales of ranitidine
- Fiji – Issued a health alert
- France – Recalled all ranitidine products
- Finland – Recalled ranitidine products from shelves and halted distribution
- Germany – Recalled all ranitidine products
- Greece – Recalls of Zantac and ranitidine by Mylan
- Hong Kong – Authorized GSK to recall ranitidine products
- India – Certain states banned ranitidine from government hospitals. Directed drug regulators to ask pharma companies to test their drugs for NDMA and ensure the drug is only sold under prescription.
- Indonesia – Suspension of production and sales and a recall of all products containing ranitidine
- Ireland – Recalled ranitidine products from pharmacies across the country
- Italy – 500 lots of products containing ranitidine have been pulled from store shelves. Recalled, banned, and stopped distribution of all ranitidine products with active ingredient made by Saraca Labs.
- Jamaica – Banned all ranitidine products
- Kenya – Recalled all ranitidine products and advised citizens to stop taking the drug
- Kuwait – Suspended the sale of and recalled ranitidine drugs from the market
- Japan – 11 domestic companies issued a voluntary recall of ranitidine products.
- Libya – Issued a warning regarding ranitidine
- Lithuania – 300,000 packs of ranitidine-containing drugs have been withdrawn from the Lithuanian market. The ban will remain in effect until marketing authorization holders provide documents proving that their medicines do not contain NDMA.
- Morocco – Recalled all ranitidine products from the market
- Namibia – Recalled and stopped distribution of all ranitidine products
- New Zealand – Recalled all ranitidine products from pharmacies and hospitals
- Norway – Recalled ranitidine products from shelves and halted distribution
- Oman – Banned the registration, importing, and distribution of all products containing ranitidine
- Palestine – Banned the manufacturing and distribution of all products containing ranitidine in all pharmaceutical forms, both domestic and imported.
- Pakistan – Banned the manufacturing and distributing of ranitidine products and recalled all products on the market
- Qatar – Banned the registration, importing, and distribution of all products containing ranitidine
- Saudi Arabia – Banned the distribution and marketing of 6 ranitidine. Recalled all products from the market and directed all pharmacies, hospitals to discontinue use of ranitidine.
- Singapore – 8 brands removed from the market and discontinued distribution of ranitidine
- South Africa – Recalled and banned marketing of all ranitidine drugs.
- South Korea – Banned the import, manufacturing and sales of 269 ranitidine-based drugs from 133 companies in the country
- Suriname – Recalled all ranitidine products
- Switzerland – Recalled all ranitidine products and launched their own investigation.
- Taiwan – Recalled and banned the distribution of all ranitidine products. Manufacturers failing to comply by the recall date will be subject to fines.
- Tanzania – Banned ranitidine from sale and distribution by prescription
- Trinidad and Tobago – Recalled and halted the distribution and import of all ranitidine products
- UAE – Banned the registration, importation and distribution of all ranitidine products
- UK – Manufacturers recalled Zantac and UK health officials issued a warning to seek alternative medications. Major retailers have recalled their branded versions of ranitidine.
- Vietnam – Recalled and halted distribution of 11 ranitidine products
