FDA Recalls – Zantac

Timeline of Zantac

Zantac® is sold prescription and non-prescription versions.  It was once touted as the best-selling drug in history.  That changed when Valisure, a small pharmacy based in New Haven, Connecticut linked “Zantac® and its generics to the carcinogen [N-nitrosodimethylamine (NDMA)] during its routine testing…”


June 2019:

Valisure first notified the U.S. Food and Drug Administration (FDA) of the NDMA contamination present in Zantac® in June 2019.

September 9, 2019:

On September 9th, 2019 Valisure petitioned the FDA and requested a recall and the suspension of sales of ranitidine from the U.S. market.   “Valisure filed a detailed petition with the Food and Drug Administration asking the agency to recall all products containing ranitidine. 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.”  Valisure reported to the FDA levels as high as 3 million nanograms per tablet and went on to explain that, “[e]ven if the manufacturing has produced a clean product, that can’t guarantee that it remains free of NDMA.”  In plain language, 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.”

September 13, 2019:

On September 13, 2019, the FDA revealed that the widely used heartburn medication known as Zantac® contains levels of a cancer-causing contaminant known as NDMA.  NDMA was previously identified in a blood pressure drug, leading to recalls.

The FDA’s investigation raised significant concerns about the risk of cancers of the liver, stomach, bladder, kidney, and other organs, especially for those who regularly used the drug.

September 23, 2019:

Sandoz Inc. issues voluntary recall of Ranitidine Hydrochloride Capsules 150mg and 300mg because of an high amount of NDMA in the Product.

November 1, 2019:

Initially, the FDA downplayed the risks caused by contamination of the already recalled heartburn drug Zantac®, saying “its tests suggest it does not cause carcinogens to form after ingestion by patients.”

Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, further downplayed the risks and said in a statement that the levels of the probable carcinogen NDMA it found in Zantac® “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

The FDA’s results of its testing on Zantac® (and some versions of its generic over-the-counter counterparts) had nine times the FDA “acceptable limit” for NDMA.

Valisure CEO, David Light, in a statement criticized FDA testing methods as “overly simplistic” and urged the agency to completely recall ranitidine and a similar drug, nizatidine.

October 18, 2019:

At first, Sanofi, the manufacturer of Zantac®, did not issue a recall even when other companies did.  The company told the New York Times that preliminary NDMA levels in the medicine “barely exceed amounts found in common foods.”

Approximately 4 months after the FDA was first alerted to the presence of NDMA in Zantac, Sanofi said it was issuing a voluntary recall of the over-the-counter formula of Zantac® that was distributed in the United States and Canada.

March 27, 2020:

By March 27, 2020, a total of 15 companies had issued ranitidine recalls in the United States.

APRIL 1, 2020:

The U.S. Food and Drug Administration (“FDA”) requested that all Ranitidine products (e.g. Zantac®) be removed from the market.   However, some companies voluntarily recalled the medication prior to the April 1st order:

  • Several companies voluntarily recalled Zantac® a few months after the FDA detected the cancer-causing chemical NDMA in several brand name and generic heartburn medications and opened an investigation.
  • After the FDA’s formal investigation began, Sanofi announced on their website that “[D]ue to inconsistencies in preliminary test results of the active ingredient used in Zantac® products, Sanofi has made the decision to conduct a voluntary recall in the U.S. and Canada as the investigation continues.” The website still has a “Buy Now” option.


The FDA ultimately stepped in and issued the recall because it “determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”

The FDA also advised “consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.”

Our Houston Personal Injury Lawyers Assist Zantac® Victims Nationwide

Morrow & Sheppard handle cases involving serious bodily injury and death caused by contaminated Zantac® and their generic counterparts’ products.

If you or a loved one has been seriously injured or developed a cancer as a result of their use of Zantac®, please contact us now for a free and confidential consultation to discuss your options.

There is no charge for the consultation.

We can be reached nationwide at 800-489-2216 or locally in Houston at 713-489-1206.

You can also reach us by entering your information into the contact form here.

We Get Results

Maritime Lawsuit
Home Explosion
Work Injury
Pipeline Leak and Explosion
Negligent Security
Industrial Accident
View More Results
Contact Us

What Our Clients Are Saying

Nick Morrow is a GREAT lawyer that really knows his job. He made me feel comfortable about hiring him to handle my case. He’s trustworthy and very... compassionate about his work. His staff is awesome also, everyone was nice and friendly to me when I visited the office. The settlement I received exceeded my expectations, it was four times what I expected. I would highly recommend Morrow and Sheppard to anyone needing legal representation. Thanks again Nick!!read more
Houston Reed
Houston R.
21:08 27 May 20
I was injured working offshore. Morrow & Sheppard handled my maritime case and won a great settlement for me. If you have been injured at work,... Morrow & Sheppard are great offshore injury lawyers.read more
tim cooper
tim C.
02:19 30 Nov 19
Morrow & Sheppard won my family a multimillion dollar settlement in a wrongful death case after my kids’ father died. The settlement money will help... make sure my family is taken care of, and that my kids can go to college. If you have a wrongful death case or a loved one dies at work, call Morrow & Sheppard. They will take care of you.read more
Dwana Moore
Dwana M.
16:26 27 Nov 19
I worked with Nick Morrow, John Sheppard, Daniel Sheppard, Patrick McGinnis, and Chris West on my maritime injury case. These guys were incredible. I... was injured badly working on a tugboat, and was forced to leave my career. These lawyers assured me I had a right to recover damages under the Jones Act, even when several other lawyers turned down my case. Morrow & Sheppard went above and beyond. They took on costs like hiring expensive experts and taking depositions so that I could be in the best position to prove my case. I watched them handle every excuse the defense lawyers threw at me, and ultimately forced the defendant’s hand in to paying me what I deserved. Morrow & Sheppard always kept me informed and up to date on my case, and developed a personal relationship with me. I would give them the highest recommendation. I still keep in touch with them, and look forward to seeing them whenever I pass through Houston.read more
Brent Lamb
Brent L.
19:50 18 Nov 19
Morrow & Sheppard helped me when my employer breached my contract. They took the case from start to finish, and won our trial. If you’ve been... injured or wronged at work, call Morrow & Sheppard.read more
Ky Evans
Ky E.
22:53 14 Nov 19
I suffered a work injury when the work vehicle I was riding in was involved in an accident with another car. Morrow & Sheppard took my case and won... a great settlement for me. If you need a work injury attorney, I highly recommend Morrow & Sheppard.read more
Dinah Rincon
Dinah R.
00:39 12 Nov 19
These guys were there when I needed help and advisement..Don’t waste your money or time going elsewhere..thank you Nick and thank you to Chris... also..great peopleread more
Steven Kemp
Steven K.
14:43 05 Jan 19
Nick Morrow and John Sheppard are the best. I was paralyzed in a work injury. Several other lawyers turned down my case. Morrow & Sheppard hired... expensive experts, took dozens of depositions, and proved my case. I saw them in court against a team of defense lawyers, and the defense lawyers didn’t stand a chance. Morrow & Sheppard took my case all the way when nobody else would. Now my family is set up for life. Throughout the process, they kept me updated and made me feel like I was more than a number. I still talk to Nick to this day. Morrow & Sheppard exceeded my expectations in every way, and I cannot recommend them enough. If you are injured at work, call Morrow & Sheppard.read more
jeff holloway
jeff H.
23:20 17 Oct 18
John Sheppard and Nick Morrow were two of the brightest stars in my law school class and my class of lawyers at Fulbright & Jaworski, one of the most... elite and prestigious law firms in Houston and Texas. I have known both of them for well over a decade now and throughout that time they have both always lived up to the highest standards of intellect, tenacity, and professionalism. They are both winners. If you need a Houston lawyer who will stand up for your rights and get you the justice you deserve, I wholeheartedly recommend Morrow & Sheppard. read more
Holt Lackey
Holt L.
20:39 17 Jul 15
John Sheppard, with Morrow & Sheppard LLP, is brilliant. On more than one occasion, he successfully represented various affiliated companies I was... part of. John is very diligent, thorough and fights hard for righteousness. There were numerous times that he helped us through extremely difficult moments. John is very professional, responsive and respectful. I highly endorse Morrow and Sheppard LLP for legal representation and/or legal assistance needs. read more
Don Knight
Don K.
21:19 15 Jul 15
My experience with John, at Morrow and Sheppard, during my company’s litigation was better than I could have imagined (considering the circumstances... of being involved in litigation). What stood out to me the most, was John’s tenacity in preparation. I later realized this came from two places, one he didn’t want to lose and two (and most importantly) he CARED so much about me getting justice. I cannot stress this enough, when you are dealing with a lawyer that truly cares, then all of the other stresses I had around the case seemed to go away. I was always kept up to date with what was going on in our case, and he always made it very clear he was just an email or call away! In addition to these attributes, he also knows the law and is willing to fight for what is right! It would be tough to find another lawyer that is as highly effective, skilled, knowledgeable, ethical and has such an impeccable reputation (which is well deserved). I would recommend Morrow and Sheppard to anyone seeking out a law firm, in the event they needed counsel.read more
Brian R
Brian R
16:04 14 Jul 15
Nick and John are a great team. They are both honest, trustworthy and have a tenacious work ethic on behalf of their clients. They stand behind... these qualities, having left partnerships at great law firms to commit 100% to achieving results for individuals and businesses. They will fight for you and I'm proud to call them clients and friends.read more
Jim Bell
Jim B.
13:58 13 Jul 15
John and Nick are outstanding lawyers. They are both extremely sharp, skilled, hard-working, and passionate about what they do. I would highly... recommend either of them to anyone looking for high-level service that also happens to be affordable.read more
Will Moore
Will M.
22:08 10 Jul 15
Morrow & Sheppard would be my first call for legal assistance. I have known Nick Morrow for years and I cannot say enough positive things about him.... He is smart, dedicated, ethical, dependable, and very thorough with every client. I would strongly recommend this firm to anyone looking for top of the line legal assistance. read more
Anne Louise Conway
Anne Louise C.
15:28 24 Jun 15
Morrow & Sheppard LLP is an outstanding law firm. I have known Nick Morrow for many years. He is honest, hardworking, and very attentive to his... clients. I could not recommend him enough for your legal needs. read more
Caroline Bean
Caroline B.
21:25 23 Jun 15
View Our Testimonials

Recent Blog Posts

Sign Up For Our Personal Injury Newsletter

Stay up-to-date! Subscribe to our newsletter to learn about personal injury law, how it works, and protecting your legal rights. You'll receive free legal advice and links to helpful resources. Simply fill out the form below to get started.