(Pictured are examples of Ranitidine products tested by Valisure’s laboratory)
Valisure discovered the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication, and first notified the FDA of its initial findings in June of 2019. On September 13th Valisure filed a detailed petition with the Food and Drug Administration asking the agency to recall all products containing ranitidine. Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the “inherent instability” of the ranitidine molecule. This means that all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body.
“There’s no acceptable cancer risk for a drug like this,”
–David Light, CEO of Valisure
Video and press links below with more information along with our FDA Citizen Petition on ranitidine and a running list of actions taken around the world.
CBS News Special: Chemical Found in Zantac Raises Concerns
NPR: Pharmacies Pull Zantac Over Concern That Contaminant Poses Cancer Risk
Bloomberg News: Leading Cancer Center No Longer Offering Zantac to Patients
WebMD: Heartburn Drugs and Cancer: What Are the Risks?
The Print (India): Explained: Why India, US haven’t recalled acidity drug Ranitidine but France & Canada have
DailyMail (UK): Zantac is Pulled from Shelves in the UK
Dr. Peter Attia Podcast
Dr. Jon Ernstoff (practicing gastroenterologist for 41 years) concerns with Zantac/Ranitidine:
How Valisure’s lab detected NDMA in Zantac/ranitidine:
Dangers of NDMA
Links to Valisure’s FDA Citizen Petition and its attachments:
Valisure Ranitidine FDA Citizen Petition
Attachment A – Chemist Affidavit – Wolfgang Hinz
Attachment B – GC-MS Ranitidine Data Report
Attachment C – Dr. Ernstoff Statement
Attachment D – ACC Resolution – Chemical Variability in Pharmaceutical Products
SUMMARY of Ranitidine investigation
Summary of actions around the world (Updated 10/3/19):
Australia – Recall on ranitidine products from pharmacies, hospitals and wholesalers
Austria – Recalling all ranitidine products
Bangladesh – Ban on sales of popular heartburn drug 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 – Recalling every product containing ranitidine
Denmark – Recalled ranitidine products from shelves and distribution
Egypt – Ban on distribution and sales of ranitidine
France – Recalling brand-name and generic Zantac from pharmacy shelves.
Finland – Recalled ranitidine products from shelves and 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 have 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
Ireland – Recalls of ranitidine from pharmacies across the country
Jamaica – Halting imports of all ranitidine products. Products already in the country are allowed to be sold.
Kenya – Government directed all chemists and suppliers nationwide to recall all Ranitidine products and people to stop taking the drug
Kuwait:- Suspending and withdrawing ranitidine drugs from the market
Italy – 500 lots of products containing ranitidine have been pulled from store shelves. Recalling, banning, and stopping distribution of all ranitidine products with active ingredient made by Saraca Labs.
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 – Withdrawn all ranitidine products from the market.
New Zealand – New Zealand College of Midwives issued a warning
Namibia – Recalled and stopped distribution of all ranitidine products
Norway – Recalled ranitidine products from shelves and distribution
Oman – Suspension of registration of ranitidine
Palestine – Suspended distribution of all products containing ranitidine in all pharmaceutical forms, both domestic and imported.
Pakistan – Ordered companies to stop manufacturing and distributing ranitidine products and recall any products on the market
Qatar – Suspended the registration, importing, and distribution of all products containing ranitidine
Saudi Arabia – Extended the recall to hospitals to discontinue and withdraw use of ranitidine. Withdraws and suspends distribution and marketing of 6 ranitidine brands.
Singapore – 8 brands removed from shelves; stopping sales
South Africa – Launching investigation
– Banned the import, manufacturing and sales of 269 ranitidine-based drugs from 133 companies in the country. “Officials found that the NDMA level detected in the seven types of ranitidine-based medications currently in circulation was as high as 53.5ppm, well above the acceptable threshold of 0.16ppm.” https://pulsenews.co.kr/view.php?year=2019&no=769561
Suriname – Recalled all ranitidine products
Switzerland – Initiated recalls. Launching their own investigation.
Taiwan – Complete recall from shelves and ban on distribution of all ranitidine products. Manufacturers failing to comply will be subject to fines.
Trinidad and Tobago – Recalled and halted distribution and import of all ranitidine products
UAE – Suspension of the registration, importation and distribution of all medicines containing ranitidine.
UK – GSK recalled Zantac from the country and health officials issued a warning to seek alternative medications
Vietnam – Recalled and halted distribution of 11 ranitidine products