Drug Safety Alerts

Sandoz Ranitidine Consumer-Level Recall

09/23/2019

On September 23, 2019 Sandoz issued a consumer-level recall of Ranitidine Hydrochloride 150 mg and 300 mg capsules. This recall was issued because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

The recall includes all quantities and lots within expiry of Sandoz Ranitidine Hydrochloride 150 mg and 300 mgCapsules. A list of the affected unexpired lot numbers of these products is provided here:

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.

Ranitidine Hydrochloride Capsules is an oral product, indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label. 

Sandoz Ranitidine Hydrochloride Capsules were distributed nationwide to wholesalers.

Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz web site, and will arrange for return of all recalled products. Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same.  Pharmacies will be asked to immediately stop dispensing Sandoz Ranitidine Hydrochloride Capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet. Patients are asked to continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.

CVS Caremark Response: CVS Caremark^® is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Ranitidine Hydrochloride Capsules to contact their prescriber.

For more information about this recall, please contact Sandoz at 1-800-525-8747, Monday through Friday, 8:30 am to 5:00 pm (ET) or visit https://www.us.sandoz.com.

You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.