Manufacturer Aurobindo Pharma USA, Inc. is voluntarily recalling the following Ranitidine products sold in the United States:

• Over-the-counter products: One lot of Ranitidine Tablets 150 mg
• Prescription products: 37 lots of Ranitidine Capsules 150 mg, Ranitidine Capsules 300 mg and Ranitidine Syrup 15 mg/mL

这次召回是由于确认污染with N-Nitrosodimethylamine (NDMA). The NDMA level is above the levels established by the U.S. Food and Drug Administration (FDA). NDMA is considered a substance that could cause cancer. OnNovember 6, 2019, the FDA stated that this is a Class II Recall for certain lots of Ranitidine products with an expiration date ofJuly 2020toMay 2021.

To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Your health and safety are important. Please talk to your doctor about this recall at your next visit.

Visithttps://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidineto learn more about this recall. You can also call the Horizon NJ Health Pharmacy Help Desk at1-800-682-9094 x81016(TTY711), Monday through Friday, 8 a.m. to 6:30 p.m. and Saturday, 8 a.m. to 4:30 p.m., Eastern Time.