Drug Safety Alerts

Aurobindo Pharma Ranitidine Products Recall

11/06/2019

On November 6, 2019, the United States Food and Drug Administration (FDA) published a notice of a consumer-level recall of Ranitidine capsules, tablets, and syrup manufactured by Aurobindo Pharma USA, Inc. This recall was issued due to the detection of N-nitrosodimethylamine (NDMA) impurity in the finished product. NDMA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

This could be a health hazard or safety risk to patients who may be using product affected by this recall. Aurobindo is advising patients who are prescribed or are taking Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to continue taking their medication and to contact their pharmacist or physician, who can advise them about an alternative treatment prior to returning their medication.

A complete list of the affected products is provided here:

CVS Caremark^® Response:

Please note: These products are not carried by CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 option 2. You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.