LITIGATION UPDATE: On December 6, 2022, Judge Robin L. Rosenberg of the Southern District of Florida dismissed all the Zantac MDL lawsuits. She claimed insufficient evidence tied ranitidine to cancer. We are appealing to the Eleventh Circuit and are hopeful for a positive outcome. In the meantime, we are not taking any new Zantac clients.
The Zantac recalls began in September of 2019 when the FDA announced it found high levels of cancer-causing NDMA (N-nitrosodimethylamine) in the blood pressure drug. Since then, more than a dozen manufacturers voluntarily recalled their Zantac (ranitidine) products. And on April 1, 2020, the FDA requested all manufacturers withdraw their products with the ingredient ranitidine from the market.
In this article, our Zantac lawyers discuss:
- 1. Has Zantac been recalled?
- 2. What is the reason for the recall?
- 3. Can I sue if I took Zantac?
- 4. Can I join a class action?
- 5. Have there been any settlements?
1. Has Zantac been recalled?
On April 1, 2020, the FDA requested that all Zantac and ranitidine manufacturers withdraw their products. Prior to then, several pharmaceutical companies have voluntarily recalled their ranitidine products. These include:
| Recall Date | Brand Name | Recalled Product | Company |
| 02/27/2020 | American Health Packaging | Ranitidine Tablets, USP 150mg | American Health Packaging |
| 01/08/2020 | Mylan Pharmaceuticals Inc. | Nizatidine Capsules 150mg and 300mg (similar to Ranitidine) | Mylan N.V. |
| 01/08/2020 | Northwind | Ranitidine Tablets 150mg and 300mg | Denton Pharma, Inc. dba Northwind Pharmaceuticals |
| 01/07/2020 | ani | Ranitidine Tablets 150mg and 300mg | Appco Pharma LLC |
| 12/17/2019 | Glenmark | Ranitidine Tablets 150mg and 300mg | Glenmark Pharmaceuticals, Inc. |
| 11/22/2019 | Amneal | Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL | Amneal Pharmaceuticals, LLC |
| 11/19/2019 | PrecisionDose | Ranitidine Oral Solution, USP 150 mg/10 mL | Precision Dose Inc. |
| 11/15/2019 | GSMS Incorporated | Ranitidine HCl 150mg and 300mg Capsules | GSMS, Inc. |
| 11/08/2019 | AHP | Ranitidine Liquid Unit Dose Cups | American Health Packaging |
| 11/06/2019 | Aurobindo & DG Health | Ranitidine | Aurobindo Pharma USA, Inc. |
| 10/25/2019 | Novitium Pharma | Ranitidine Hydrochloride Capsules 150 mg and 300 mg | Novitium Pharma |
| 10/25/2019 | Lannett Company, Inc. | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL | Lannett Company, Inc. |
| 10/23/2019 | Dr. Reddy’s, Kroger, Walgreens, and others | Ranitidine Tablets & Capsules | Dr. Reddy’s Laboratories Ltd. |
| 10/23/2019 | Sanofi | Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products) | Sanofi |
| 10/23/2019 | Perrigo Company plc | Ranitidine (all pack sizes) | Perrigo Company plc |
| 09/25/2019 | Apotex Corp. | Ranitidine Tablets 75mg and 150mg | Apotex Corp. |
| 09/23/2019 | Sandoz Inc. | Ranitidine Hydrochloride Capsules | Sandoz Inc. |
The acceptable daily NDMA intake is only 96 nanograms. Some ranitidine samples the FDA tested contain 3 million nanograms.
2. What is the reason for the recall?
Various ranitidine products have been recalled for containing high NDMA levels. According to the US Environmental Protection Agency (EPA), NDMA is a “probable human carcinogen.” Scientists already know that it causes cancer in animals.
The online pharmacy Valisure claims ranitidine molecules are inherently unstable. It reports that during human digestion, the drug changes into NDMA. In other words, NDMA is a byproduct of Zantac.
The FDA takes a different stance. It claims the NDMA is an impurity in the Zantac drugs themselves. It does not acknowledge that digesting ranitidine may cause NDMA to materialize in the human body. But it does acknowledge that storing ranitidine at higher-than-room temperatures may increase NDMA exposure.
Either way, Zantac is being recalled for its cancer-causing risks due to NDMA.
3. Can I sue if I took Zantac?
Anyone diagnosed with cancer after taking ranitidine may have grounds to sue the Zantac manufacturers. People with any the following cancers have the strongest case:
- Pancreatic cancer,
- Bladder cancer,
- Leukemia,
- Liver cancer,
- Stomach cancer,
- Intestinal cancer (including colorectal cancer),
- Esophageal cancer,
- Prostate cancer (only for victims diagnosed at age 65 or younger),
- Non-Hodgkins lymphoma, or
- Multiple myeloma
Healthy people who took Zantac may also be able to sue the manufacturers. But their payout would probably be just the price they paid for the drugs.
Ranitidine users who have not been diagnosed may want to consult their doctor. It may be in their interest to screen for these cancers. And they should always seek medical help if they start displaying symptoms.
Learn about other Zantac side effects.
4. Can I join a class action?
Class actions are appropriate for Zantac users who have not gotten cancer. If they can show they bought Zantac and were unaware of the cancer risks, they could be entitled to refunds. There are several class action lawsuits pending.
For Zantac users who developed cancer, their cases will likely join an MDL (multi-district litigation). Unlike class actions, all the cases remain separate. But to expedite litigation, one judge makes the pretrial rulings for all of them.
Currently, there is a Zantac MDL (#2924) out of the Southern District of Florida (West Palm Beach). The presiding judge is Robin L. Rosenberg. It is expected that thousands of cases will join.
5. Have there been any settlements yet?
Not yet. Zantac recalls began just in 2019. So the MDL litigation (discussed above) is still in its early stages.
Eventually, the MDL judge will allow a handful of cases to go trial. What happens at these bellwether trials will be the starting point of negotiations.
If the bellwether trials result in a big verdict for the plaintiffs, the ranitidine manufacturers may be willing to offer large settlements to the remaining plaintiffs. The goal for plaintiffs’ attorneys is to achieve a high enough settlement to cover each client’s compensatory damages. These include medical bills, lost wages, and pain and suffering.