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# GSK, Sanofi Report Zantac-related Probes
- URL: https://www.fdaweb.com/gsk-sanofi-report-zantac-related-probes/
- Published: 2020-08-04T12:00:00.000Z
- Updated: 2026-09-14T16:23:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147353

GlaxoSmithKline (GSK)and Sanofi have separately disclosed in financial reports that they are being investigated by the U.S. Justice Department over alleged False Claims Act violations in the companies’ marketing and subsequent recall of heartburn drug Zantac (ranitidine). Earlier this year, FDA asked manufacturers ([see earlier story](https://www.fdaweb.com/pull-zantac-and-generics-from-market-fda/)) to withdraw all prescription and over-the-counter ranitidine products from the market immediately due to NDMA contamination that can increase over time. An agency [news release](https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market?ref=fdaweb.com) said the agency determined that the N-Nitrosodimethylamine impurity in some ranitidine products increases over time and when stored at higher than room temperature and may result in consumer exposure to unacceptable levels of the impurity.

[GSK said ](https://www.gsk.com/media/6064/q2-2020-results-announcement.pdf?ref=fdaweb.com)that in June it received a Civil Investigative Demand from Justice “related to Zantac pursuant to the False Claims Act.” [Sanofi also said](https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/en/investors/docs/2020%5F07%5F29%5FHY%5Ffinancial%5Freport%5FEN.pdf?la=en&hash=BF3E4CD00D130D985E9EFB8C5169EB86&ref=fdaweb.com) it received a notice from Justice and the U.S. Attorney’s Office for the Eastern District of Pennsylvania over the “alleged failure to disclose to the federal government information about the potential presence of N-Nitrosodimethylamine (NDMA). The notice requests information and documents from Sanofi including applications and communications with FDA.”

Additionally, both companies reported being sued by the New Mexico Attorney General over their Zantac products. “The complaint brings claims for alleged violations of the New Mexico Unfair Practices Act, violations of the New Mexico False Advertising Act, violations of the New Mexico Public Nuisance Statute, common law public nuisance, and negligence,” Sanofi explained.