(Pictured are examples of Ranitidine products tested by Valisure’s laboratory)
New Haven, CT, September 13, 2019 — 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.
Bloomberg BusinessWeek: The Problem with Drug Recalls
The Washington Post: A tiny pharmacy is identifying big problems with common drugs, including Zantac
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. 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 12/17/19):
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
