Attention Members: Manufacturer recall of Ranitidine Tablets, Capsules and Syrup

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

This recall is due to confirmed contamination 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. On November 6, 2019, the FDA stated that this is a Class II Recall for certain lots of Ranitidine products with an expiration date of July 2020 to May 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.

Visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine to learn more about this recall. You can also call the Horizon NJ Health Pharmacy Help Desk at 1-800-682-9094 x81016 (TTY 711), Monday through Friday, 8 a.m. to 6:30 p.m. and Saturday, 8 a.m. to 4:30 p.m., Eastern Time.

Published on: January 1, 2020, 15:17 PM ET
Last updated on: January 2, 2020, 01:53 AM ET