November 1, 2019 – the FDA states that the level of NDMA in Zantac is not dangerous
On November 1, 2019, the FDA released the results of its NDMA testing. The levels of NDMA ranged between 0.03 and 2.85 parts per million in 18 different products, and the agency said these concentrations are consistent with levels in common foods such as grilled or smoked meats.
October 21, 2019 – Colorado resident files Zantac bladder cancer lawsuit
Mark Allan Blake, a resident of Colorado, filed a lawsuit against Sanofi, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, and Chattem Inc. on October 21, 2019. The man began taking prescription Zantac in 1996. Subsequently, he started using over-the-counter Zantac, which he would take four times a week. In 2018, Blake was diagnosed with bladder cancer, a disease which he attributes to ranitidine use.
According to the lawsuit, medical studies have found that Zantac can produce high levels of NDMA since at least 1981. "This was not done by accident or through some justifiable negligence. Rather, Defendants knew that it could turn a profit by convincing consumers that Zantac was harmless to humans, and that full disclosure of the true risks of Zantac would limit the amount of money Defendants would make selling Zantac," the complaint says.
October 18, 2019 – Sanofi, the brand name Zantac drug maker, also issues a recall
Sanofi issued a recall for over-the-counter brand-name Zantac 150, 150 Cool Mint, and Zantac 75. This was the first brand-name recall. The pharmaceutical company also recalled these drugs in Canada.
October 17, 2019 – the FDA releases a second method of detecting NDMA in ranitidine
The FDA developed another method of determining whether NDMA is present in ranitidine, known as Liquid Chromatography-Tandem Mass Spectrometry.
September 28 to October 2, 2019 – multiple retailers cease selling Zantac and its generics
During this period of time, multiple retailers across the country, including Walgreens, CVS Pharmacy, Rite-Aid, and Walmart, suspended all sales of brand-name Zantac and its generics.
September 24, 2019 – Sandoz, the first company to issue a voluntary Zantac recall
On September 24, 2019, the global leader in generic pharmaceuticals Sandoz issued a voluntary recall on Zantac. The specific drug the company took off the market is Ranitidine Hydrochloride Capsules 150mg and 300mg. Sandoz has not received any reports of negative health effects occurring due to the use of the product as part of this recall.
September 13, 2019 – the FDA issues a statement that some ranitidine drugs may contain NDMA
Dr. Janet Woodcock, the FDA's Director for Drug Evaluation and Research, issued a statement informing the public that some ranitidine medicines may contain NDMA. The agency released a method known as Liquid Chromatography-High Resolution Mass Spectrometry, which is used to determine the presence of the probable carcinogen in ranitidine. The FDA recommended manufacturers test their products and send samples to the agency for further testing.
September 9, 2019 – the laboratory Valisure discovers NDMA, a probable human carcinogen, in Zantac
In June 2019, the independent pharmacy and laboratory Valisure found N-nitrosodimethylamine – NDMA, for short – in multiple samples of Zantac. The Food and Drug Administration was promptly alerted and informed about the problem, and Valisure sent a Citizen's Petition urging the recall of all the affected drug lots. N-nitrosodimethylamine is a probable human carcinogen, meaning that it may lead to the development of malignant diseases such as liver cancer, stomach cancer, bladder cancer, pancreatic cancer, and esophageal cancer. It was found in Zantac by the Valisure researchers in excess of 3,000,000 ng per tablet, a concentration significantly higher than what health agencies determined to be safe for human ingestion based on lifetime exposure.