Glenmark Pharmaceuticals, Inc. Ranitidine Tablets Recall

Date: 01/06/20

On December 18, 2019, the U.S. Food and Drug Administration (FDA) announced that Glenmark Pharmaceuticals, Inc. was recalling Ranitidine Tablets to the consumer level due to the products containing N-Nitrosodimethylamine (NDMA).

The FDA press release states the following:

Glenmark Pharmaceutical Inc., USA is voluntary recalling all lots of Ranitidine Tablets (150 mg, 300 mg) due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the FDA, based on FDA-validated tests. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

Please immediately check your medical supplies, quarantine any drug products impacted, and do not administer them. The NDC numbers associated with Glenmark’s recalled products are as follows: Ranitidine 150 mg tablets (NDC 684620-248-60, 684620-248-01, 684620-248-05) and Ranitidine 300 mg tablets (NDC 684620-249-30, 684620-249-01, 684620-249-20).

Review the FDA’s full press release

For questions or concerns, please reach out to Envolve Pharmacy Solutions’ Pharmacy Department by calling 1.800.782.2221.