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February 14, 2020

Heartburn drug manufacturers recall Zantac (ranitidine) due to “unacceptable levels” of toxic, carcinogen NDMA

The FDA recently announced multiple new recalls of generic heartburn medicine Zantac (ranitidine) tablets that may contain N-Nitrosodimethylamine (NDMA), a substance that the World Health Organization says may cause stomach, bladder, kidney, pancreatic, colon and other cancers in humans.

The recalls by drug manufacturers Appco Pharma and Northwind Pharmaceuticals are the latest in a series affecting certain batches of name brand and generic versions of the popular antacid due to NDMA. Mylan also recalled batches of a similar prescribed antacid nizatidine due to the toxic substance.

Appco Pharma’s recall includes certain batches of prescription-only 150mg and 300mg capsules that are set to expire in April or May of 2021. Northwind Pharmaceuticals’ recall affects all unexpired lots of 150mg and 300mg ranitidine tablets that were packaged by Denton Pharma.

Similar recalls were announced in recent months by manufacturers of generic ranitidine including Glenmark Pharmaceutical Inc., Sandoz Inc., and Apotex Corp. Sanofi, which manufacturers Zantac, the name-brand version of the drug, also announced a recall in October 2019.

The FDA began investigating NDMA in blood pressure and heart failure medications in 2018. The agency also found “unacceptable levels” of the toxin in some ranitidine products, H2 (histamine-2) blockers used to decrease the amount of acid in the stomach and treat conditions such as heartburn and indigestion.

The FDA continues to investigate and has asked all ranitidine manufacturers to test their products for NDMA levels, and to send samples to the FDA to aid in its review.  

Motley Rice medical attorneys have extensive experience litigating for patients who have suffered severe adverse effects and complications caused by prescription and over-the-counter drugs, including heartburn medications. In addition to Zantac claims, our attorneys are reviewing claims of chronic kidney disease and failure caused by proton pump inhibitors (PPI), used to treat GERD, frequent heartburn, ulcers, esophagitis and other conditions related to the over-production of stomach acid.

For more information or to discuss a potential claim, contact medical attorneys Carmen Scott and Dan Lapinski by email or call 1.800.768.4026.