The People's Perspective on Medicine

Another BP Nitrosamine Drug Recall and Zantac (Ranitidine)

You won't believe this. There is a nitrosamine drug recall for the BP med losartan. Other countries are recalling ranitidine (Zantac) for heartburn. Why?

Are you getting drug contamination fatigue? We would not blame you. There is a new blood pressure nitrosamine drug recall. This time it is from Torrent Pharmaceutical Limited of Ahmedabad, India.

The company announced on September 23, 2019 that several lots of its 50 mg and 100 mg bottles of losartan and losartan + hydrochlorothiazide were contaminated with NMBA. This comes just days after Canadian, European and Taiwanese drug regulators announced the recall of ranitidine (Zantac) because of the nitrosamine NDMA.

Are You Getting Tired of the Nitrosamine Drug Recall?

Remember the boy who cried wolf? The story tells about a boy charged with guarding sheep. He thought it would be a good joke to cry wolf and have the villagers come running. Two times they came and there was no wolf. They didn’t pay attention the third time he cried out and the wolf ate his sheep.

Sadly, the nitrosamine drug recall problem is all too real, but we are beginning to feel like that little boy. We have cried wolf so many times it almost seems as if no one is listening anymore, even though there really has been a wolf each time. The Food and Drug Administration seems content to let contamination fatigue set in.

The Sartan Scandal:

Here we go again. Another day, another drug contamination crisis! Ever since the valsartan blood pressure pill scandal over a year ago, FDA officials have been playing catch up.

The agency was caught flat-footed when European drug regulators started warning physicians and patients that millions of sartan-type pills were contaminated with probable carcinogens.

The first warning about valsartan came from the European Medicines Agency on July 5, 2018. We sent out our first Special Health Alert from The People’s Pharmacy on July 15, 2018. Chinese-made valsartan was contaminated with NDMA (N-nitrosodimethylamine). This was the first nitrosamine drug recall.

We reported that over 16 million valsartan prescriptions were dispensed every year in the U.S. There have been countless recalls of valsartan, irbesartan and losartan since. Millions of people have been affected and tens of millions of pills have had to be trashed.

New Losartan Recall

Torrent just announced its nitrosamine drug recall recall of losartan (50 mg and 100 mg pills) because of NMBA (N-Nitroso-N-methyl-4-aminobutyric acid). This now makes over 300 lots of blood pressure medications that Torrent has recalled since last summer.

If 300 lots doesn’t sound like much, consider that many of these lots involve bottles that contain 1000 pills. We love it when a company tells you to check for a lot number on your bottle of pills to determine whether your medicine is affected. This is almost always a fruitless task.

Pharmacists pour pills out of big bottles (with 1000 pills) into little amber bottles and slap a label on them that was generated by a computer. Rarely, if ever, does that label contain a lot number. That means that you may not be able to identify whether the most recent nitrosamine drug recall affects you.

Other companies that have recalled sartan-type BP drugs include some of the biggest generic manufacturers in the world. They include Mylan, Teva, Sandoz Novartis, Macleods, Aurobindo, Camber, Major and Prinston to name a few.

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Another Nitrosamine Drug Recall: Ranitidine/Zantac

The FDA has also been blind-sided by another contamination calamity. This time it’s not a blood pressure medicine, though. It’s a widely used heartburn drug known as ranitidine (Zantac).

An online pharmacy called Valisure tests all batches of drugs it dispenses for quality and purity. After testing Zantac and various generic ranitidine products, the company sent a Citizen Petition to the FDA.

It says in part that Valisure’s tests:

“…detected extremely high levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine. The Food and Drug Administration (“FDA”) has established a permissible daily intake limit for the probable human carcinogen, NDMA, of 96 ng. Valisure has detected NDMA in excess of 3,000,000 ng per tablet when analyzing ranitidine products, likely due to the inherent instability of the ranitidine molecule.”

Not surprisingly, the FDA is scrambling. In an interview with Bloomberg (Sept. 13, 2019), the FDA’s director of the Center for Drug Evaluation and Research, Janet Woodcock, said that the agency had detected NDMA in OTC and prescription versions of Zantac.

She went on to add:

“We don’t think this poses an immediate hazard to human health so we’ll have an ongoing process to determine whether recalls are needed.”

The FDA has tried to reassure the millions of people who took contaminated irbesartan, losartan and valsartan blood pressure pills that the cancer risk was too low to worry about. But judging from the messages on our website, patients are not placated.

One reader wrote:

“I took Valsartan for over three years. Now I have lung nodules that have been followed for two years. I’d like to know just what this drug causes, as far as damage to an organ system. I’m not a smoker and never have been. I just hope my nodules aren’t related to having taken this medicine.”

We may never know how many cases of cancer might have been caused by contaminated blood pressure pills or tainted ranitidine. The FDA can reassure people that the risk is small, but that is little comfort to our readers.

Valisure Says: Recall Ranitidine!

Valisure, the company that discovered the contamination of ranitidine/Zantac, has strongly suggested that the FDA:

“…recall and suspend sale of all lots of all products containing ranitidine.

“In addition to the instructions for disposal and/or return in the recall notices, issue additional guidance to the public for the safe disposal of ranitidine, given the recognized potential that the drug may degrade to form the probable carcinogen NDMA in municipal wastewater treatment plants and impact the public water supply.”

Other countries are taking Valisure’s advice. We have discovered that Taiwan’s FDA has recalled 38 stomach medications containing ranitidine. Canada and some countries in Europe are also recalling ranitidine and/or Zantac. 

We find it distressing that the FDA did not discover this contamination problem on its own. We are also alarmed that the agency seems more concerned about reassuring the public than issuing a recall at the time of this writing.

We have been alerting readers of The People’s Pharmacy about our concerns involving the manufacturing, shipping and storing of drugs for years. Just listen to our interview with Katherine Eban about her book, Bottle of Lies: The Inside Story of the Generic Drug Boom to get some idea of the size and scope of the problem. 

Stay tuned; we may be crying wolf, or rather “nitrosamine drug recall,” a few more times before this story is finished.

What Do You Think?

Share your thoughts about the nitrosamine drug recall in the comment section at the bottom of the page. Do you find the FDA’s actions laudable or deplorable? Are you concerned that so many drugs have been contaminated with nitrosamines or do you think this is a minor annoyance at worst? We would like to read your perspective.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I’ve been on ranitidine for years. What do you recommend as the best alternative to replace it? And are there any withdraw symptoms when stopping it?

We are not aware of withdrawal symptoms for ranitidine. Both cimetidine (Tagamet) and famotidine (Pepcid) are in the same class and either could be used in place of ranitidine.

What a mess. I asked my Dr. about the ranitidine and she said: “Ask the pharmacist if a recall has been issued”. Drs are not inclined to act independently of the FDA and pharmacies. So while the rest of the world recalls drug the FDA is fiddling. If you are already a cancer patient it is very disturbing to find out you are taking a drug with extremely high levels of a carcinogen, and nobody with authority to do something seems inclined to act. I am self-unmedicating and making adjustments.

We used to take Ranitidine, but fortunately we switched to famotidine or cimetidine quite a while ago. Are these two drugs safe?

So far as we know. But ranitidine was not on our radar before the story broke.

I have been on Losartan for more than 6 years. I have become tired and almost lethargic in the mornings after taking this drug. The cardiologist who prescribed this drug for me seems not to be really concerned. I hate the drug with a passion. Some days I just don’t do Losartan 100mg once per day. I was also prescribed Ranitidine to take at night to wean off Pantaprasole. I know I am getting older, but I sure do Not want these poisonous drugs killing me and having such a poor quality of life. What has happened to making sure these drugs are safe since these pharmaceutical companies are taking trillons to the bank!

I am now having Valisure fill my scripts for irbesartan and prevastatin. Peace of mind, peace of mind.

I have taken losartan for at least 5 or 6 years. Recently they discovered nodules on my lungs. Now I need a CT scan every 6 months. I have never smoked in my life and generally avoid being around smokers. I asked my primary about the losartan and he seemed unconcerned. My cardiologist took me off of it. I’m very concerned.

I’m retired military and get losartan and ranitidine/Zantac from the military. I wonder if they will notify us if their meds are affected?

I took Aciphex (a PPI) for 11 years for GERD (acid reflux) which resulted in stage lll kidney disease. Note: I should have never been on that drug for that long.
Upon my kidney disease diagnosis (PPI’s are known to damage kidneys) I took myself off the Aciphex and switched to Zantac (Ranitidine). Now I am learning Zantac is only a concern for the FDA. This is beyond disturbing!
I can only think the FDA is being very lax and irresponsible for their wait and see attitude. For those of us who are dependent on a medicine to help control heartburn and acid reflux, this poses a serious concern. The mere fact that they haven’t pulled it off the market and begun extensive study is scary. The minute there is a question on any medication, that item should be pulled to protect our citizens…..not wait and see how many are harmed.

I just hung up with Perrigo, makers of generic ranitidine for CVS. I gave them the lot number of the tablets I have, doesn’t sound like there is a recall yet. They read to me the latest FDA statement about ranitidine. Also said they are “aware of the ongoing FDA investigation. While they are not aware of the presence of NMBA in their products, in light of the latest information they are proceeding with additional testing.” I read that the manufacturer Sandoz is recalling capsules, doses 150 & 300. It would be helpful to know if capsules are the problem, or if anything (capsules included) containing ranitidine is a problem. I don’t take it often, won’t take it anymore.

My husband has taken Zantac for decades. It’s not an optional drug for him. His doctor switched him to generic Pepcid a week ago, but now he’s complaining of stomach pains. Is it possible to get rebound after discontinuing Zantac?

Ranitidine has been working well for me. Hence, I hate to stop taking it and go to something else that does not work well for my heartburn problem without knowing that the ranitidine pills I have are contaminated. How do I have these pills tested for contamination?

I take Losartan and my daughter takes Zantac. 😠
Last time Losartan was recalled, I took it back to the CVS pharmacy and they replaced it with more Losartan. Then I get a letter in the mail from my insurer, Aetna Advantage, with a 4-page warning about the Losartan! A ridiculous pattern was established: get refill from pharmacy, get letter from insurance.
I haven’t trusted the FDA for decades and they are increasingly politicized and not serving the public. Like the rest of government. 👎🏼

Maybe it’s time for the FDA’s Inspector General to start looking into this horrendous issue before it’s too late for millions of Americans! Why are we told to stop smoking. eat healthy and exercise when they are giving us poisonous pills?

Recall bacon!! Bacon is loaded with nitrosamines

You are absolutely right!! Our FDA could care less about the people in this country. They don’t protect us. They protect big pharmaceutical companies! If they cared even a little then how come these contaminated drugs are even getting into this country? Shouldn’t they check the drugs before they give them to the unsuspecting public. We believe that my mother is dying of pancreatic cancer caused by taking “Sartan,” drugs brand and generic. Believe me they don’t care one bit who this kills. They just want to protect the source of money! Big pharmacy! I am all for breathing down the backs of the FDA to make them do their job or heaven forbid even more to protect the people they are supposed to be serving!!

I’ve asked my pharmacy to package my losartan in the original bottle of 90 pills so that I can check the lot number when the next recall is issued. Where can I find the lot numbers covered on the latest recall of Torrent losartan?

Here is the link on the FDA’s website. I could not find the lot numbers but will keep searching:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-0?ftag=MSFd61514f

Here is what I found:

NDC Product Name, Strength and Package Count Batch Number Expiration Date
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E009 12/31/2020
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E009 12/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E018 02/28/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D051 11/30/2020
13668-118-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. 4P04D007 07/31/2020

Is there any way to buy uncontaminated Zantac?

We do not have a good answer. Check with Valisure. Their testing suggests it is inherent in the drug and the way it is processed in the body

I take Valsarten and Zantac, but when I brought the recall up with my doctor, she dismissed it and all but refused to give me something else. I am 73 years old -what do I do now?

There are alternatives to both valsartan and ranitidine. Your doctor could prescribe an ARB (sartan) that is not on the recall list. There are H2 antagonists such as cimetidine or famotidine that are not a problem

I contacted Optum Rx years ago when I discovered my Losartan was manufactured in India. I was assured the FDA conducted stringent inspections and that it was safe. I replied to them, “until it isn’t.” I also complained to my primary doctor at the time and he said 70% of prescriptions were manufactured in India or China and made no attempt to find me a U.S. manufactured replacement. It is disgraceful that the FDA has failed the American people from the cancer-causing ingredients in these prescriptions. Instead of trying to impeach President Trump, perhaps our legislators should turn their attention to the prescription crisis going on in this country. Europe is always seems to be ahead of us when it comes to protecting their citizens.

We’re going to be seeing more and more of this as long as drugs are manufactured in unregulated countries. The current FDA is not up to the job of doing that because Trump has gotten rid of many scientists in all federal regulatory agencies. Insurance companies want to make more money by insisting on cheaper generic drugs. What a mess!

It just goes to prove that the FDA is in bed with big Pharma and could care less about the health of the citizenry it was established to protect. It will never change, politics i.e. money usurps moral obligation every time.

Darn, and Zantac (generic) is the one I have to take because it does not affect cardiac conductivity as much as Pepcid (I also take methadone is the reason). I think I will only take it when I’m desperate for heart burn relief. Certainly not regularly anymore. And I think it’s very sad that the FDA seems to be playing catch-up.(again).

We get generic Zantac as a prescription through the VA. Will they know the lot number? Will they care and contact the veterans who might be affected? We’ll find out tomorrow.

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