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FDA Asks for Recalls of Sanofi's Zantac and All Generic Versions

By Brian Orelli, PhD – Apr 1, 2020 at 1:07PM

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The agency says there is a risk that some of the heartburn pills may contain unacceptable levels of NDMA, a possible carcinogen.

The Food and Drug Administration has requested that Sanofi (SNY -0.08%) recall all of its Zantac heartburn products because the agency found that the amount of N-Nitrosodimethylamine (NDMA) in those products increases over time and when they are stored at higher than room temperatures. While consuming low levels of N-Nitrosodimethylamine has not been found to cause any health risks -- and the substance is found in foods and water -- sustained ingestion of higher levels is believed to increase the risk of developing cancer.

The request also extends to generic products that contain ranitidine, the active ingredient in Zantac, which are made by Novartis (NVS 0.05%), Endo (ENDP -6.06%), Dr. Reddy's Laboratories (RDY 1.30%), Perrigo (PRGO -3.96%), and others.

Pharmacy shelves

Image source: Getty Images.

The FDA has been investigating the levels of NDMA in ranitidine medications since September of last year. Novartis, Mylan (MYL) and other drugmakers have voluntarily recalled some of their generic products because NDMA was detected in them, but this is the first widespread recall of all the products.

The agency said that it had not found unacceptable levels of NDMA in many of the samples that it tested. However, the agency can't be sure how long the products have been stored, nor can it know the temperatures they were stored at. So it decided to ask that every ranitidine product be recalled.

The FDA is advising patients to stop taking products that contain ranitidine. The agency suggests patients dispose of the medications at home rather than bringing them to drug take-back locations, as such errands should be avoided to reduce people's risk of exposure to COVID-19.

There are plenty of other over-the-counter and prescription drugs that treat heartburn. "FDA's testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec)," the agency said in a statement.

Brian Orelli has no position in any of the stocks mentioned. The Motley Fool recommends Mylan. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Sanofi Stock Quote
$37.22 (-0.08%) $0.03
Novartis AG Stock Quote
Novartis AG
$74.65 (0.05%) $0.04
Perrigo Company plc Stock Quote
Perrigo Company plc
$36.17 (-3.96%) $-1.49
Viatris Inc. Stock Quote
Viatris Inc.
Endo International plc Stock Quote
Endo International plc
$0.12 (-6.06%) $0.01
Dr. Reddy's Laboratories Limited Stock Quote
Dr. Reddy's Laboratories Limited
$50.55 (1.30%) $0.65

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