Update on H2 blocker Ranitidine (Zantac) Recalls

(updated April 1, 2020)

UPDATE APRIL 1, 2020: The FDA has recalled ALL versions of ranitidine because FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
https://www.fda.gov/safety/medical-product-safety-information/all-ranitidine-products-zantac-press-release-fda-requests-removal

Historical: The following ranitidine (generic for heartburn drug Zantac) products have been recalled in the U.S.: Brand name Zantac (Sanofi); Over-the-counter (OTC) generic tablets with CVS, Walgreens, Walmart, and Rite-Aid labels; some prescription and OTC capsules, tablets, and syrups labeled by Glenmark Pharmaceuticals, Precision Dose Inc., Golden State Medical Supply, Amneal, Aurobindo, DG Health, Sandoz, Teva,  Perrigo, Novitium Pharma, Apotex, and Lannett. The products have been recalled due to possible contamination with NDMA, the same carcinogen involved in the recent losartan/valsartan recalls.  Read more and get specific lot numbers at the FDA here: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine.

January 8, 2020 a recall happened for ranitidine products by Appco Pharma LLC and Northwind Pharmaceuticals. In addition, Mylan initiated a recall for its nizatidine H2 blocker antacid product on January 8, 2020.
The FDA does not have one comprehensive list of ranitidine recalls (as it does for valsartan products), but provides links to separate announcements for each company initiating a recall.

On Friday, November 1 2019, the FDA released lab results for ranitidine (brand name Zantac) and nizatidine (brand name Axid) they have completed so far. Results indicate nizatidine had much lower levels of NDMA than ranitidine, which is also what independent pharmacy Valisure had found during their product testing. Valisure brought the problem to the FDA's attention through a "Citizen Petition," as they also did last year because of concerns about lab test results for ARB valsartan/losartan/irbesartan blood pressure medications.

FDA equates the amount of NDMA found in ranitidine to the amount of carcinogen one might receive when eating grilled or smoked meat. Nevertheless, some versions of the over-the-counter medicine had as much as nine times the "acceptable limit" for NDMA. FDA has set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine. Here are the laboratory testing results by product and manufacturer name: https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine

In Canada, at least four companies announced recalls of ranitidine: Apotex, Pro Doc Limitee, Sanis Health and Sivem Pharma, along with previously announced recalls by Sandoz (Novartis). https://uk.reuters.com/article/us-health-canada-heartrburn/health-canada-says-four-more-companies-recalling-versions-of-zantac-id Many countries worldwide have ranitidine recalls, so consumers outside the U.S. should check with the appropriate regulatory agency for more information.

H2 blocker, Antacid, or PPI? How to choose a heartburn treatment at the drug store

Heartburn is an uncomfortable digestive condition that most of us have experienced at one time or another. The feeling of burning below the breastbone or in the throat is symptomatic of stomach acid moving its way up through the esophagus.This can happen after a meal containing food like onions, caffeine, peppermint, chocolate, fried foods, sodas, and alcohol. Certain drugs, including aspirin, ibuprofen, and osteoporosis treatments can also irritate the esophagus and cause heartburn.

How can you avoid this condition? Most doctors would first tell you to avoid the foods and medicines that trigger your heartburn. There are also some items in your kitchen (like apple cider vinegar) that might bring relief for an upset stomach. But when it is late at night (and the offending meal has already been eaten), you might be seeking relief by looking at treatments inside your medicine cabinet or at the drug store. Since three distinct categories of heartburn medicines are now available over-the-counter, make sure you choose the right OTC medicine for you. The following categories of treatments are listed from mildest to strongest, in terms of side effects risk:

  • Antacids The safest of the OTC medications for heartburn. They have always been available without a prescription. These treatments neutralize excess acid in the stomach.
    Examples: Tums, Maalox, Milk of Magnesia, Gaviscon
  • Histamine2 Blockers (H2 blocker) Available OTC since 1995. These drugs partially block production of stomach acid.
    Generic names: famotidine, cimetidine, nizatidine, ranitidine* , (see above information for recent recall notices)
    Brand name examples: Zantac, Pepcid, Tagamet, Axid
  • Proton Pump Inhibitor (PPI) These drugs act by blocking the secretion of stomach acid and are used to treat severe cases of heartburn (or Gastroesophageal Reflux Disease - GERD). GERD has been defined as heartburn episodes that occur frequently or at least two times a week.
    Generic names: omeprazole, esomeprazole, lansoprazole.
    Brand name examples: Prilosec (OTC in 2003), Nexium (OTC in 2014), Prevacid (24 hour OTC version in 2009; Rx version still available), Zegerid OTC
    While PPI drugs are very effective at reducing symptoms, severe side effects can occur, especially with long-term use. Sometimes after stopping the drug, heartburn symptoms increase, leading the patient to start taking it again. However, the exacerbated heartburn symptoms are sometimes actually "rebound symptoms" and not indicative that the patient really has GERD. The rebound symptoms often resolve with time, and those patients may successfully use occasional H2 blockers, antacids, and/or dietary changes to combat heartburn.
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If no relief is gained from OTC treatments, a visit to the doctor is in order. The doctor may recommend prescription-only version of a PPI drug. Many of the prescription-only PPIs are for treating more serious cases of GERD or stomach ulcers and may be used in conjunction with other medicines to eliminate H. Pylori bacteria. Examples include Aciphex (rabeprazole) and Dexilant (dexlansoprazole), Protonix and Pantoprazole Sodium.
Non-PPI drugs for treating active stomach ulcers that are to be taken short term (eight weeks or less) include Carafate (sucralfate).

Sources and More Reading:
Links above on drug names go to patient reviews
Questions and Answers about NDMA carcinogen in Ranitidine: FDA Q&A
Medline Plus Drug Information, such as omeprazole (used in Prilosec and Zegerid)
Berkeley Wellness Letter: Help for Heartburn and GERD
Related information on recall of valsartan products for NDMA contamination

Originally posted April 22, 2019