American Health Packaging recently announced a voluntary ranitidine recall due to concerns that their products may contain carcinogenic impurities. Ranitidine is more commonly known as generic Zantac.

According to the U.S. Food and Drug Administration (FDA), which announced the recall on Feb. 27, 2020, eleven lots of ranitidine tablets from American Health Packaging are being voluntarily recalled in response to another recall by manufacturer Amneal Pharmaceuticals. These lots were manufactured by Amneal and later repackaged by American Health.

The affected ranitidine products in this recall are the 150 mg tables in 100 count blister cartons. Lot numbers 179516, 179745, 180712, 180819, 181403, 182544, 183155, 183236, 185739, 186600, and 186702 are included in the ranitidine recall. The lots have expiration dates ranging from Dec. 31, 2019, to Dec. 31, 2020.  Earlier recalls from 2019 covered different ranitidine product lots by Sanofi and Apotex.

“American Health Packaging has not received any reports of adverse events that have been confirmed to be directly related to this recall,” the recall announcement notes.

Individuals who have these products are encouraged to stop using the medication immediately. These customers can contact Inmar Pharmaceuticals Services with any questions at 800-967-5952 from 9 a.m. to 5 p.m. EST, Monday through Friday.

In the case of adverse reactions, consumers are directed to report these problems to Amneal Drug Safety by phone at 1-877-835-5472, Monday through Friday, 8 a.m. to 6 p.m. EST, or via e-mail at DrugSafety@amneal.com.

Ranitidine Recall: Background

Ranitidine, also sold under brand name Zantac, is a histamine-2 blocker that may be used to treat stomach conditions such as ulcers, GERD, and more. The medications treat these conditions by decreasing the amount of stomach acid produced.

Ranitidine recalls were prompted by concerns that the products are contaminated with N-Nitrosodimethylamine (NDMA). NDMA is typically an environmental contaminant that is found in food and water. However, the contaminant can also occur as a result of industrial processes. Unfortunately, NDMA is a probable human carcinogen.

The FDA’s acceptable daily intake of NDMA is 96 ng per day or 0.32 parts per million for ranitidine. Some of the ranitidine recall lots have exceeded this level while other lots have been recalled because of potential but unconfirmed contamination. In some cases, pharmacies have decided to take their ranitidine products off their shelves “out of an abundance of caution” despite no recalls being in place.

Emery Pharma, an independent lab in Alameda, Calif. has also noted that levels of the Zantac carcinogen NDMA may rise if stored in high temperatures over time.

The idea of taking a medication contaminated with a carcinogen can be daunting, but the FDA notes there isn’t enough evidence for the agency to recommend people stop or continue their medications.

The agency notes that people should speak to their medical professional before making any changes to their treatment. “Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options,” the FDA notes. “Multiple drugs are approved for the same or similar uses as ranitidine.”

The FDA also notes that not all lots of ranitidine have been recalled, so there are several options for consumers who need to take ranitidine to manage their health condition.

Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) have reportedly shown no NDMA contamination through FDA testing.