Recall Spans OTC, Prescription Antacids Sold Under Various Brands

Dr. Reddy’s Laboratories is voluntarily recalling all over-the-counter and prescription ranitidine medications sold in the United States due to confirmed contamination with the probable carcinogen N-Nitrosodimethylamine (NDMA). The widespread recall appeared in the November 13, 2019, US Food and Drug Administration (FDA) Enforcement Report.

“To date, Dr. Reddy’s has not received any reports of adverse events related to the recall of Dr. Reddy’s ranitidine products,” the company stated in an October 23, 2019, announcement. “The recall includes all quantities in the United States that are within expiry.” 

The recalled products are sold under various brands, including Dr. Reddy’s, Kroger, and Walgreens. Over-the-counter ranitidine tablets are used to prevent and treat heartburn. Prescription ranitidine capsules are used in the treatment of ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid. 

The recall affects all ranitidine products with expiration dates between September 2019 and March 2022:

• ranitidine capsules (Dr. Reddy’s, prescription), 300 mg, 30-count bottles (NDC 5511-1130-30) and 100-count bottles (NDC 5511-1130-01);
•  ranitidine capsules (Dr. Reddy’s, prescription), 150 mg, 60-count bottles (NDC 5511-1129-60) and 500-count bottles (NDC 5511-1129-05);
• ranitidine tablets (CDMA, over the counter), 150 mg, 24-count bottles (NDC 63868-480-24) and 50-count bottles (NDC 63868-480-50);
• ranitidine tablets (Dr. Reddy's, over the counter), 150 mg, 24-count bottles (NDC 55111-404-34);
• ranitidine tablets (Sam's Club, over the counter), 150 mg, 190-count bottles (2 x 95 tray) (NDC 150062076, UPC code 078742089720);
• ranitidine tablets (Geri-Care, over the counter), 150 mg, all counts (NDC 57896-717);
• ranitidine tablets (HCA, over the counter), 150 mg, 95-count bottles (NDC 43598-808-62) and 220-count bottles (NDC 43598-808-65);
• ranitidine tablets (Kroger, over the counter), 150 mg, 24-count bottles (NDC 30142-505-34) and 50-count bottles (NDC 30142-505-50);
• ranitidine tablets (Target, over the counter) 150 mg, 40-count bottles (NDC 11673-849-40);
• ranitidine tablets (Thirty Madison, over the counter), 150 mg, 24-count bottles (NDC 71713-203-02) and 95-count bottles (NDC 71713-203-05);
• ranitidine tablets (Walgreens, over the counter), 150 mg, 24-count bottles (NDC 0363-0010-34), 65-count bottles (NDC 0363-0010-61), 95-count bottles (NDC 0363-0010-62), and 200-count bottles (NDC 0363-0010-01);
• ranitidine tablets (Walmart, over the counter), 150 mg, 65-count bottles (NDC 49035-404-61), 130-count bottles (NDC 49035-404-13), and 220-count bottles (NDC 49035-404-65);
• ranitidine tablets (CDMA, over the counter), 75 mg, 30-count bottles (NDC 63868-482-30) and 60-count bottles (NDC 63868-482-60);
• ranitidine tablets (CVS, over the counter) 75 mg, 30-count bottles (NDC 69842-871-30), 80-count bottles (NDC 69842-871-80), and 160-count bottles (NDC 69842-871-37);
• ranitidine tablets (Dr. Reddy's, over the counter),75 mg, 60-count bottles (NDC 55111-131-60); 
• ranitidine tablets (Geri-Care, over the counter), 75 mg, all counts (NDC 57896-715);
• ranitidine tablets (Kroger, over the counter), 75 mg, 30-count bottles (NDC 30142-131-30); and
• ranitidine tablets (Walgreens, over the counter), 75 mg, 30-count bottles (NDC 0363-0131-30) and 80-count bottles (NDC 0363-0131-80).

Dr. Reddy’s Laboratories initiated the recall October 1, 2019. On November 5, 2019, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

—Jolynn Tumolo