Companies Recalling Zantac / Ranitidine Due to Concerns Regarding the Presence of NDMA
Zantac and generic ranitidine medications—used to treat heartburn, ulcers, gastroesophageal reflux disease (GERD), and general indigestion and stomach upset—have been the subject of several recalls over the past few months, with more expected to be forthcoming.
These recalls have all been implemented after testing of ranitidine medications had confirmed the presence of high levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen that is linked to cancers. The results of this testing were reported to the FDA earlier this year.
Is There a Recall on Zantac and Ranitidine?
YES. Though Sanofi, which manufacturers brand named Zantac, was the market leader in ranitidine medications, many other companies produced it as well. The following have recalled either some or all of their products from the market because of NDMA concerns:
- Sandoz (generic ranitidine hydrochloride capsules)
On September 23, 2019, Sandoz recalled all quantities and lots within expiry because of confirmed contamination with NDMA.
- Apotex Corp. (ranitidine tablets 75 mg and 150 mg)
On September 25, 2019, Apotex recalled tablets to the retail level after the FDA found that some medications contained NDMA.
- Sanofi (Zantac 150, Zantac 150 Cool Mint, Zantac 75)
On October 22, 2019, Sanofi recalled all over-the-counter Zantac products in the U.S. because of FDA testing results.
- Perrigo Company (all pack sizes of ranitidine)
On October 23, 2019, Perrigo recalled all pack sizes of ranitidine worldwide due to the possible presence of NDMA.
- Reddy’s (ranitidine tablets & capsules)
On October 23, 2019, Dr. Reddy’s recalled all ranitidine medications sold in the U.S. due to confirmed contamination with NDMA above levels established by the FDA. Dr. Reddy’s generic products were also sold under Kroger, CVS, Walgreens, and CDMA brand products.
- Lannett Company (ranitidine syrup 15 mg/mL)
On October 25, 2019, Lannett recalled all lots within expiry of ranitidine syrup due to confirmed NDMA contamination.
- Novitium Pharma (ranitidine hydrochloride capsules 150 mg and 300 mg)
On October 25, 2019, Novitium recalled all quantities and lots within expiry of ranitidine hydrochloride capsules in the U.S. because of the potential for NDMA contamination.
- Aurobindo (ranitidine)
On November 6, 2019, Aurobindo recalled 1 lot of ranitidine tablets 150 mg to the retail level; also recalled 37 lots of ranitidine capsules 150mg and 300 mg, and ranitidine syrup 15 mg/mL to the consumer level due to the detection of NDMA in the finished product.
- American Health Packaging (ranitidine liquid unit dose cups)
On November 8, 2019, American Health Packaging recalled eight lots of ranitidine syrup 150 mg/10 mL liquid unit dose cups to the consumer level due to the detection of trace amounts of NDMA. This recall was initiated in response to the recall by the manufacturer, Lannett Company (above), which included affected lots that were repackaged by American Health Packaging.
- Amneal (ranitidine tablets, 150 mg and 300 mg, and ranitidine syrup 15 mg/mL)
On November 8, 2019, Amneal recalled 150 mg and 300 mg ranitidine tablets, and ranitidine syrup 15 mg/mL to the consumer level because of potential contamination with NDMA.
- Golden State Medical Supply (ranitidine HCl 150 mg and 300 mg capsules)
On November 15, 2019, Golden State Medical Supply recalled all quantities and lots within expiry of ranitidine HCl 150 mg and 300 mg capsules to the consumer level because of the presence of NDMA above levels established by the FDA. This recall was based on the manufacturer’s recall (Novitium Pharma above).
- PrecisionDose (ranitidine oral solution 150 mg/10 mL
On November 19, 2019, Precision Dose recalled 5 lots of ranitidine oral solution 150 mg/10 mL to the consumer level because of the potential presence of NDMA. This recall was initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals, above).
Online Pharmacy Finds NDMA in Ranitidine Products Tested
On September 13, 2019, the Food and Drug Administration (FDA) issued a statement alerting patients and healthcare professionals of NDMA found in samples of ranitidine. The agency stated it had learned that some of these medications, including Zantac, contained NDMA.
This was not the first time the FDA had found NDMA in medications and raised concerns. Blood pressure and heart failure medications had also tested positive for NDMA in 2018, resulting in several recalls of products like valsartan and losartan.
It wasn’t until an online pharmacy named “Valisure” tested ranitidine products, however, that the FDA became aware that NDMA could be present in stomach-acid-reducing drugs too. Valisure discovered NDMA in its routine testing of every batch of medication across multiple manufacturers, and first notified the FDA of its findings in June 2019. In September 2019, the company submitted a petition requesting the FDA to recall and suspend sales of all Zantac/ranitidine from the U.S. market.
According to Valisure’s investigation, the NDMA in ranitidine was not an impurity or a contaminant, as the FDA had labeled it, but rather a natural byproduct of ranitidine digestion:
“Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule. This means that all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body.”