Glenmark Recalls Prescription Ranitidine

December 18, 2019 – Glenmark Pharmaceuticals has halted distribution of both its 150mg and 300mg prescription ranitidine tablets due to the potential for N-nitrosodimethylamine (NDMA) levels in excess of the FDA’s currently established limits. The company has also recalled all unexpired lots on the United States market.

NDMA is considered a probable human carcinogen, or a substance with the potential to cause cancer. The substance is found in the environment, including certain water and food supplies, and has been a source of concern for ranitidine manufacturers since September 2019, when a pharmacy alerted the FDA to NDMA present in samples of ranitidine products. Since then, multiple manufacturers have recalled both prescription and over-the-counter ranitidine. In some cases, manufacturers have halted production and distribution as well.

The FDA does not believe the amount of NDMA found in ranitidine products to date represents an immediate threat to consumers. The agency has advised patients to speak to their physician or pharmacist about switching to another medication if they are concerned about taking ranitidine. Many medications available in the U.S. are FDA-approved for the same or similar indications as ranitidine, which is used to treat certain gastrointestinal conditions.