Zantac Recall Lawsuit

Read below for more information about the Zantac and ranitidine recall lawsuit. This article will be updated as more information comes in.

UPDATE: (Oct. 28, 2019)
Sanofi, manufacturer of Zantac, said it would be recalling the over-the-counter medication in both the United States and Canada. This comes on the heels of the Food and Drug Administration alert to the public that the drug contains low levels of a cancerous contaminant, NMDA.

There have a been a handful of recalls of the generic version of Zantac, as you can read below.  It has been recalled from major chain pharmacies such as CVS, Walgreens, and Walmart. Additionally, Canada has requested that all ranitidine products would be temporarily suspended from distribution.

The French drug maker made a statement that said, “Sanofi is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence.”

Sanofi initially debated the validity of testing by Valisure, an online pharmacy that first detected NDMA.

UPDATE (Oct. 3, 2019)
Walmart announced it would be suspending the sales of Zantac and ranitidine medications. The withdrawal of the over-the-counter medication indicates a growing concern over the substance that may cause cancer that has been found in the medication. The company said customers can return products to Walmart of Sam’s Club stores for a refund.

Additionally, CVS and Walgreens have suspended sales of the medication. However, there has not been a recall initiated by the FDA of Zantac or other ranitidine products.

UPDATE (Sept. 23, 2019) – Sandoz Inc. announced it would be voluntarily recalling all quantities of generic ranitidine hydrochloride capsules from the US consumer market.

The recall comes just ten days after another voluntary recall of Zantac was initiated by Sanofi. The recalls are due to the presence of a human carcinogen, NDMA. The Ranitidine products affected were 30 count, 60 count, and 500 count bottles. For the full list of the products, including lot numbers and expiration dates, click here.

Both customers and distributors will be notified via mail and website. Pharmacies have been asked to immediately stop distributing them to patients, and return any unused capsules.

UPDATE (Sept. 26, 2019) Apotex Corp. announced it was voluntarily recalling ranitidine tablets in 75mg or 150mg formats at the recall level.

Ranitidine hydrochloride is an over-the-counter (OTC) medication used for heartburn from acid indigestions or a sour stomach. It also treats erosive esophagitis, gastroesophageal reflux disease or GERD, and Zollinger-Ellison syndrome.

But some brand and generic versions of ranitidine medications contain nitrosamine impurity called N-nitrosodimethylamine (NDMA). NDMA is considered a human carcinogen and has been found in a handful of other medications recently.

NDMA is considered an environmental contaminant and can be found in water or foods, including meat, dairy products, or vegetables.

Ranitidine tables can be found at Rite Aid, Walmart, and Walgreens. Customers who are concerned about stopping the medication should first speak to a health care professional.

Sept. 13, 2019 – A certain medication used to treat millions of people each year with gastrointestinal problems was recalled due to the presence of a human carcinogenic.

The generic ranitidine is a drug used in many antacid and antihistamine products. It can be found under the brand name Zantac, manufactured by Sanofi, and other generic versions manufactured by many other companies.

It’s considered an oral, over-the-counter (OTC) prescription drug. It’s also known as an H2 (histamine-2) blocker, which helps decrease stomach acid. Additionally, it can be used to treat ulcers of the stomach and intestines, gastroesophageal reflux disease, reflux esophagitis, post-operative peptic ulcers, Zollinger-Ellison Syndrome, duodenal ulcer, benign gastric ulcer, and many other conditions that reduce acid in the gastric system.

Zantac helps prevent a variety of stomach and gastrointestinal troubles in millions of people worldwide. But drug officials in both Europe and the United States are concerned about the presence of N-Nitrosodimethylamine, or NDMA, recently detected by an online pharmacy.

According to the International Agency for Research on Cancer “NDMA has been classified [by IARC] as probably carcinogenic to humans.” It can actually be found as a byproduct of cooked or cured meats, such as bacon.

NMDA was detected by New Haven, Connecticut-based online pharmacy, Valisure, which tests all medications it dispenses to buyers. Valisure immediately alerted the Food and Drug Administration to the high levels of NDMA it detected in both Zantac brand and generic versions.

An email to Bloomberg from Ashleigh Koss, a spokeswoman for Sanofi, said the company “takes patient safety seriously, and we are committed to working with the FDA.”

Zantac is made in Mexico but Sanofi sources its ingredients from Spain, she said. The Zantac and generic versions can be found at major pharmacies such as Walgreens Boots Alliance Inc., CVS Health Corp. and Walmart Inc.

NDMA Found in Other Medications

The FDA has been concerned about the growing presence of NMDA in other medications as well. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year,” the agency said in a press announcement. “In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

Valisure filed a petition with the FDA to recall Zantac and generic medications that contain NMDA. However, the FDA wrote back and said the levels were low. Yet, Valisure called them “excessive.”

Valisure detected NDMA levels as high as 3,000 micrograms in Zantac and generic versions. Compared to 17 micrograms in blood-pressure medication that made headlines last year, many people are concerned about the carcinogen levels.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the agency isn’t ready to begin a recall until more samples have been collected.

“We don’t think this poses an immediate hazard to human health so we’ll have an ongoing process to determine whether recalls are needed,” she said.

The FDA doesn’t recommend people stop taking Zantac or generics, but other medications are available if people are concerned.

This story will be updated as it develops.