Dr. Reddy’s Recalling Heartburn Drugs Over Cancer-Causing Chemical

October 23, 2019 Updated: October 23, 2019

Dr. Reddy’s Laboratories Ltd. and its subsidiaries announced the voluntary recall of its ranitidine medicines that are used to treat heartburn, the U.S. Food and Drug Administration (FDA) said on Wednesday.

The products were found to have N-Nitrosodimethylamine, or NDMA, which is a known carcinogen. According to the Environmental Protection Agency, NDMA is unintentionally introduced into manufacturing through various chemcial reactions, but it is “classified as a B2 (probable human) carcinogen based on the induction of tumors in both rodents and nonrodent mammals exposed” to it.

“This recall follows the USFDA’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,” the FDA statement said.

As of now, Dr. Reddy’s said it has not received any reports of illnesses related to patients taking the drug.

“Dr. Reddy’s Ranitidine products can be identified by NDC numbers on the product label. All Ranitidine products with expiration dated September 2019 to June 2021 are being recalled,” the FDA said. A full list of drugs included in the recall can be accessed via the FDA website.

Walmart, CVS Pharmacy, and Walgreens also announced they would stop selling medications containing ranitidine due to the potential of NDMA contamination.

In November, drug manufacturer Novartis also said it would not distribute any ranitidine medicines made by Sandoz.

The FDA’s full statement reads:

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries, together referred to as “Dr. Reddy’s”) confirms it had intiatiated a voluntary nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA. This recall follows the USFDA’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.

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.

Ranitidine is available as an over-the-counter (OTC) and prescription drug. Over-the-counter (OTC) ranitidine tablets are used to relieve heartburn associated with acid indigestion and sour stomach. OTC Ranitidine Tablets are also used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. Prescription ranitidine capsules are prescribed for the short-term treatment of active duodenal ulcer; maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers; treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis); short-term treatment of active, benign gastric ulcer; maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers; treatment of GERD (Gastroesophageal reflux disease); treatment of endoscopically diagnosed erosive esophagitis; and for maintenance of healing of erosive esophagitis.

Dr. Reddy’s Ranitidine products can be identified by NDC numbers on the product label. All Ranitidine products with expiration dated September 2019 to June 2021 are being recalled.

RECOMMENDED