Zantac Recall Update: Another Company Recalls Ranitidine Heartburn Drug Over Cancer Fears

Aurobindo Pharma USA is the latest company to issue a voluntary recall on ranitidine products, joining several other companies in pulling batches of the drug over concerns regarding the impurity N-nitrosodimethylamine (NDMA).

The U.S. Food and Drug Administration issued a recall notice on November 6 affecting the following products distributed nationally to Aurobindo Pharma USA and AuroHealth wholesale and distributor customers between September 28, 2018 and September 19, 2019:

• Ranitidine Tablets 150mg with the batch number NBSB19001DA3 (expiry date: February 2021)
• Ranitidine Capsules 150mg with the batch numbers RA1518001-A (expiry date: July 2020), RA1518002-A (expiry date: July 2020), RA1518002-B (expiry date: July 2020), RA1518003-A (expiry date: July 2020), RA1518004-A (expiry date: August 2020), RA1518005-A (expiry date: August 2020), RA1518005-B (expiry date: August 2020), RA1518006-A (expiry date: August 2020), RA1518007-A (expiry date: September 2020), RA1518008-A (expiry date: September 2020), RA1518009-A (expiry date: September 2020), RA1518010-A (expiry date: October 2020), RA1518011-A (expiry date: November 2020), RA1518012-A (expiry date: November 2020), RA1518013-A (expiry date: November 2020), RA1518014-A (expiry date: November 2020), RA1518015-A (expiry date: November 2020), RA1519003-A (expiry date: May 2021), RA1519003-B (expiry date: May 2021), RA1519004-A (expiry date: May 2021)
• Ranitidine Capsules 300mg with the batch numbers RA3018001-A (expiry date: July 2020), RA3018002-A (expiry date: July 2020), RA3018003-A (expiry date: July 2020), RA3018004-A (expiry date: August 2020), RA3018005-A (expiry date: August 2020), RA3018006-A (expiry date: August 2020), RA3018007-A (expiry date: September 2020), RA3018008-A (expiry date: September 2020), RA3018009-A (expiry date: September 2020), RA3018010-A (expiry date: October 2020), RA3019001-A (expiry date: January 2021), RA3019002-A (expiry date: January 2021), RA3019003-A (expiry date: May 2021)
• Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg/5 mL) with the batch numbers UI1519001-A (expiry date: May 2021), UI1519002-A (expiry date: May 2021), UI1519003-A (expiry date: May 2021), UI1519004-A (expiry date: May 2021)

"Patients who prescribed or are taking Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL should continue taking their medication," the notice states. "Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication."

Aurobindo Pharma USA is organizing returns for the products affected by the recall via Qualanex. Information on how to return the medication will be laid out in a recall letter sent to distributors and customers.

In the meantime, customers have been advised to contact their medical practitioner if they experience any adverse health effects from the recalled products.

Why is ranitidine being recalled?

Ranitidine is prescribed to relieve heartburn, which it does by blocking the effect of histamine at the histamine H2 receptors—thus reducing gastric acid secretion.

Some ranitidine medications have been found to contain above-recommended levels of NDMA, a naturally-occurring compound found in food, water, air pollution and industrial processing that has been declared a probable carcinogen, as per the definition given by the International Agency for Research on Cancer (IARC).

As such, the FDA has advised companies to issue a voluntary recall on any products that are found to have levels of NDMA that exceed the acceptable daily intake, equivalent to 96ng or 0.32 parts per million.

Testing is ongoing but levels of NDMA found in ranitidine products so far are similar to the levels found in grilled and smoked meats, the FDA revealed in an announcement published November 1. The drugs have not yet been tested in the human body to find out how ranitidine forms NDMA.

"Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines," the announcement states.

"The decision of the FDA to investigate the drug—and of companies like CVS, Walmart, Sandoz and Apotex Corp. to voluntarily recall the drugs—is the administration being very cautious," Michael D. Green, Professor of Law at Wake Forest University School of Law, told Newsweek in September.

Green said he recommends consumers on ranitidine look for an alternative but added they should not be too concerned if they are taking or have taken the product.