Drug Safety Alerts

Amneal Ranitidine Expanded Consumer-Level Recall

11/22/2019

On November 22, 2019, Amneal published an announcement stating the consumer-level recall of Ranitidine 150 mg tablets and Ranitidine 300 mg tablets issued by Amneal on November 8, 2019 was expanded to include all lots within expiry. This recall was issued because of potential N-nitrosodimethylamine (NDMA) amounts above levels established by the FDA. 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.

A list of the affected products is provided here:

Ranitidine 150 mg and 300 mg tablets manufactured by Amneal are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Amneal Pharmaceuticals, LLC. has stated that it has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets 150mg and 300mg Tablets manufactured by Amneal are prescription oral products. 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.

This could be a health hazard or safety risk to patients who may be using product affected by this recall. Amneal has advised that consumers who have Ranitidine 150 mg tablets and/or Ranitidine 300 mg tabletsthat are being recalled should stop using the products.

CVS Caremark Response: Because of this action, CVS Caremark^® is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Ranitidine 150 mg tablets and Ranitidine 300 mg tablets manufactured by Amneal to contact their prescriber.

For more information about this recall, health care providers may contact Amneal Drug Safety at 1-877-835-5472, Monday through Friday, 8:00 am to 6:00 pm (ET) or investors.amneal.com.

You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.