FDA Answers Questions about Ranitidine (Zantac) Recall

FDA, ranitidine, zantac, medication recall

News sources across the United States have reported on the recall of popular antacid medication Zantac (ranitidine).  The U.S. Food and Drug Administration’s (FDA) recall notice warns patients and healthcare providers that certain Zantac and ranitidine products manufactured by Apotex Corp. may be contaminated with N-nitrosodimethylamine (NDMA).  Consequently, the FDA announced a second medication recall of ranitidine hydrochloride capsules manufactured by Sandoz, Inc.  in September 2019.

Naturally, consumers are concerned about the recall.  Millions of people use Zantac brand or store brand ranitidine products for relief of indigestion or sour stomach.  Consumers are asking the FDA for information about the recall and how they can protect their health.

FDA Questions and Answers about Ranitidine Recall

To help consumers better understand the situation, the FDA is answering some of the most common questions the agency is receiving about the recall.

Why is the FDA Recalling Zantac?

Zantac and store brand ranitidine is being recalled due to impurities found in certain samples.  The impurity is N-nitrosodimethylamine (NDMA).  NDMA is classified as a probable human carcinogen.  It is the same impurity that led to the numerous blood pressure medication recalls that are ongoing.

NDMA is a naturally-occurring substance, and is a known environmental hazard.  It is also known to be present in water, food, meat, vegetables and dairy products.  The FDA warns that even though it is a natural substance, too much can be dangerous.

What Store Brand Ranitidine is Being Recalled?

Consumers may find ranitidine removed from shelves at the following retailers:

  • Wal-Mart (Equate brand)
  • Walgreens (Wal-Zan brand)
  • Rite-Aid

CVS suspended sales of Zantac and CVS Health brand ranitidine products after the recall, but it is not part of the recall.  The products in the recall are 75mg and 150mg tablets sold over-the-counter (OTC).

Can I Get Cancer from Taking Zantac or Ranitidine with NDMA?

The FDA says that they do not know enough about safe NDMA levels to tell consumers to stop taking the product altogether.  However, the agency also does not have enough information to give the “all clear.”

What Should I do if I Take Zantac or Ranitidine Regularly?

If you regularly take OTC Zantac or ranitidine, you can talk to your doctor or pharmacist about an alternative.  Some alternatives that may alleviate your symptoms include:

  • Pepcid (famotidine)
  • Tagamet (cimetidine)
  • Nexium (esomeprazole)
  • Prevacid (lansoprazole)
  • Prilosec (omeprazole)

If you are taking prescription Zantac or ranitidine, talk to your doctor before stopping or changing your medication.

What Should Doctors Know about the Recall?

The FDA urges healthcare providers to talk to their patients about Zantac and ranitidine products.  Patients who are currently taking ranitidine may be able to take an alternative medication, such as those listed above.  Healthcare providers who have samples of ranitidine that are subject to the recall should not give them to patients or have them available.

What is the FDA Doing About the Contamination?

The FDA is continuing tests on ranitidine products across multiple manufacturers.  The tests are to determine the possible impact of contamination among patients taking ranitidine products.  The FDA has established a new testing method for manufacturers and regulators to use to identify NDMA and other impurities in ranitidine products.

In addition to their own testing, the FDA is asking manufacturers to conduct their own and to send samples to the FDA for scientific analysis.  The results of the ongoing investigation will help the FDA determine the best course of action to protect patients.  During this time, additional manufacturers and retailers may suspend ranitidine products.

What Should I Do if I Have Recalled Ranitidine or Zantac?

If you have ranitidine or Zantac products that are in this recall, you may be able to return the product for a refund.  Contact the retailer or manufacturer to find out if you qualify for a refund.

If you experience adverse events while taking Zantac or ranitidine products, you should report it to your healthcare provider.  You can also report it to the FDA via the MedWatch reporting program.

Should I Contact a Lawyer if I Take Recalled Zantac or Ranitidine?

Manufacturers have a duty to consumers to make sure their products are safe.  In the case of Zantac and ranitidine, there is clearly a problem with manufacturing, though the FDA does not yet know exactly where the problem is.  In any case, these medications pose a potential risk to the health and safety of consumers.

If you have experienced adverse events while taking Zantac or ranitidine products, you can certainly contact a lawyer to find out about your legal rights.  As a consumer, you should not bear the burden of a dangerous or defective product.  That is the manufacturers responsibility.  To find out more, contact Drug and Device Watch.  We can advise you of your legal rights and how best to proceed.