What You Should Know About The FDA Recall of Zantac
The Food and Drug Administration (FDA) continues to announce recalls of the popular heartburn medication Zantac and its generic formulation ranitidine due to contamination with the known carcinogen N-Nitrosodimethylamine (NDMA). The latest announcements of five additional Zantac and ranitidine recalls come a month after the agency announced initial recalls by Sandoz and Apotex and alerted the public that NDMA had been found in samples of ranitidine. These recalls include both prescription and over-the-counter Zantac.
Zantac has been on the market for over thirty years and millions of people have taken these medications. For anyone currently taking these drugs, you should immediately contact your doctor to discuss your options.
Zantac Recall Summary
Precision Dose Ranitidine Recall
On November 19, 2019, repackaging company Precision Dose Inc. voluntarily recalled 5 lots of Ranitidine Oral Solution–USP 150mg/ 10mL from the market. The ranitidine product is being recalled due to potential NDMA presence above the standards approved by the Food and Drug Administration.
The recall was initiated after manufacturer Amneal Pharmaceuticals, LLC) issued a voluntary recall which included lots repackaged by Precision Dose Inc.
Golden State Ranitidine Recall
On November 15, 2019, repackaging company Golden State Medical Supply, Incorporated (GSMS, Inc.) voluntarily recalled all quantities and lots of Ranitidine HCl 150mg and 300mg capsules due to the potential presence of NDMA above levels approved by the Food and Drug Administration.
The voluntary recall comes after GSMS, Inc received a recall notice from manufacturer Novitium on October 25, 2019 and initially recalled 7 lots of Ranitidine HCl 150mg and 12 lots of Ranitidine HCl 300mg capsules on November 6, 2019.
American Health Ranitidine Recall
On November 8, 2019, American Health Packaging voluntarily recalled 8 lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150mg/10mL Liquid Unit Dose Cups from the consumer market due to an “unexpected impurity” of NDMA detected in the finished products at levels deemed unsafe by the Food and Drug Administration.
The recall comes in response to manufacturer Lannett Company, Inc.’s voluntary recall of ranitidine products which included affected lots that were repackaged by American Health Packaging.
Amneal Ranitidine Recall
On November 8, 2019, Amneal Pharmaceuticals, LLC voluntarily recalled Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL that were distributed directly to wholesalers, distributors, retailers, and re-packagers due to potential NDMA levels deemed unacceptable by Food and Drug Administration standards.
Lannett Ranitidine Recall
On October 28, 2019 the FDA announced that Lannett Company, Inc. recalled all lots of its prescription ranitidine syrup. The recall includes Lannett’s ranitidine oral solution prescribed in 15mg/mL doses due to the confirmed presence of NDMA.
Novitium Pharma Ranitidine Recall
On October 25, 2019, the FDA confirmed that Novitium Pharma LLC recalled all lots of its over-the-counter Ranitidine Hydrochloride capsules in the United States. Novitium’s ranitidine recall includes all lots of 150 mg and 300 mg dosages sold in 30, 60, 100, and 500 count bottles. The FDA announcement states that the recall was due to potential unsafe levels of NDMA found in the capsules.
Perrigo Ranitidine Recall
On October 23, 2019, the FDA announced that Perrigo Company plc issued a worldwide recall of all lots of its over-the-counter ranitidine products. The announcement states that Perrigo halted shipments of its ranitidine products on October 8 due to the possible presence of NDMA. The Perrigo recall includes many popular ranitidine products, including the Publix over-the-counter store brand.
Dr. Reddy’s Ranitidine Recall
On October 23, 2019, the FDA announced that Dr. Reddy’s Laboratories, LTD. issued a voluntary recall of all lots of its ranitidine products – both prescription and over-the-counter – sold in the United States on October 1. This recall includes lots of ranitidine sold under store brand names at Walgreens, Target, Walmart, Kroger, and CVS. The ranitidine recall was initiated after product testing confirmed unsafe levels of NDMA. For a full list of products recalled under the Dr. Reddy’s ranitidine recall, visit the FDA recall page.
Sanofi Zantac OTC Recall
The FDA also confirmed on October 23, 2019 that Sanofi recalled all lots of its Zantac OTC (over-the-counter) medications sold in the United States and Canada on October 18. The company cited “inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products” as the reason for the recall. The Sanofi Zantac OTC recall includes all lots of Zantac 150, Zantac 150 Cool Mint, and Zantac 75.
Apotex Ranitidine Recall
On September 25, 2019, the FDA announced that Apotex Corp. voluntarily recalled its over-the-counter Ranitidine Hydrochloride tablets on a precautionary basis due to concerns of NDMA contamination. The Apotex ranitidine recall applied to 75 mg and 150 mg tablets sold under store brand names at Rite Aid, Walmart, and Walgreens pharmacies.
Sandoz Ranitidine Recall
On September 23, 2019, the FDA announced that Sandoz Inc. recalled all lots of its Ranitidine Hydrochloride capsules sold over-the-counter in the United States due to confirmed NDMA contamination. Sandoz is a subsidiary of the Swiss pharmaceutical conglomerate Novartis. The Sandoz ranitidine recall applies to 14 lots of Ranitidine 150 mg and 300 mg capsules sold in 30, 60, and 500 count bottles.
What Is Zantac?
Zantac is a medication that limits the production of stomach acid and belongs to a class of medications known as H2 blockers. It is sold as a generic under the name of its active ingredient, ranitidine. Zantac is sold over-the-counter to treat heartburn and acid indigestion, and prescribed for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease, and certain stomach and esophagus conditions.
What Is NDMA?
NDMA is classified as a probable human carcinogen that can form as a byproduct of industrial processes or, as in Zantac, from a reaction with the body. The chemical can be found in small quantities in drinking water but in levels that are considered generally harmless. The NDMA found in the recalled Zantac and ranitidine products is above levels considered safe by the FDA. NDMA had previously been found in the blood pressure medication Valsartan, which prompted a string of product recalls starting in July 2018.
NDMA exposure in Zantac and ranitidine has been linked to digestive system cancers such as:
- Stomach cancer
- Intestinal cancer (both of the small and large intestines)
- Esophageal cancer
- Prostate cancer
- Pancreatic cancer
- Non-Hodgkin’s Lymphoma
- Multiple Myeloma
- Bladder cancer
- Stomach cancer
- Colorectal Cancer
- Liver Cancer
- Kidney Cancer
Additionally, in babies born to mothers who took Zantac consistently throughout their pregnancies, NDMA has been linked to cancers, including brain cancers, in young children.
How We Can Help
GoldenbergLaw is currently investigating cases where an individual has taken Zantac or ranitidine and been diagnosed with one of the cancers listed above. Contact our Minnesota cancer attorneys today for a free consultation or call 612-436-5026. We have over 30 years of experience fighting negligent drug companies and have national leadership in NDMA contamination cases, let us deliver the Gold standard you deserve.