Drug Safety Alerts

AvKARE Ranitidine Capsules Consumer-Level Recall

10/25/2019

On October 25, 2019, AvKARE issued a consumer-level recall of prescription Ranitidine capsules manufactured by Dr. Reddy’s Laboratories and distributed by AvKARE. This recall was issued due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA. This recall follows the FDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of ranitidine. To date, Dr. Reddy’s has not received any reports of adverse events related to the recall of Dr. Reddy’s Ranitidine products. The recall includes all quantities in the US that are within expiry.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

A complete list of the affected products is provided here.

Risk Statement: 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.

CVS Caremark Response:

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 capsules manufactured by Dr. Reddy’s Laboratories and distributed by AvKARE to contact their prescriber.

For more information, please contact AvKare at 1‑855‑361‑3993 or visit www.avkare.com.

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