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Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.

Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

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.

Amneal Pharmaceuticals, LLC. has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP), 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.

Customers who purchased the impacted product directly from Amneal can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) which are being recalled should stop using the product and can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.