Drug Safety Alerts

Dr. Reddy’s Laboratories Ranitidine 150 mg and 300 mg Capsules Consumer-Level Recall

10/23/2019

On October 23, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of all lots of prescription Ranitidine capsules manufactured by Dr. Reddy’s Laboratories. 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 Laboratories has not received any reports of adverse events related to the recall of Dr. Reddy’s Laboratories Ranitidine products. The recall includes all quantities in the US that are within expiry.

A list of products and lot numbers affected by this recall are 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.

Please note: These products are carried by the CVS Caremark Mail Service Pharmacies.

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 prescription Ranitidine capsules manufactured by Dr. Reddy’s Laboratories to contact their prescriber.

For more information, contact Dr. Reddy’s Laboratories at 1-888-375-3784, Monday through Friday, 8:00 am to 8:00 pm (ET). You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.