Zicam Recall Lawsuit: FDA Halts Marketing Due to Loss of Sense of Smell

Austin Kirk

By Austin Kirk
Posted June 16, 2009

ADD YOUR COMMENTS 49

The use of nasal gel and spray versions of the cold remedy Zicam can cause long-lasting or permanent loss of smell, leading the FDA to warn the manufacturer that they are no longer permitted to sell certain products in the United States until they provide data establishing that they are safe and effective. The Zicam recall lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals who have lost their sense of smell or taste after using the over-the-counter cold remedy.

>>INFORMATION: Zicam Recall Lawsuits

A Zicam recall was issued after the FDA warned consumers not to use the following products:

  • Zicam Cold Remedy Nasal Gel
  • Zicam Cold Remedy Nasal Swabs
  • Zicam Cold Remedy Swabs, Kids Size (Previously Discontinued)

The FDA said that it has received at least 130 reports of users losing there sense of smell as a side effect of Zicam. In some cases these Zicam problems surfaced after only one use, and could leave users with a permanent disability.

Although the FDA never approved Zicam because it is classified as a homeopathic product, these safety issues now require the manufacturer to go through a formal review process before they will be permitted to market Zicam again.

Given the minimal benefits of the product, which is used to reduce the severity of a self-resolving condition like the common cold, it seems unlikely that the FDA would approve the cold remedy.

The confirmed reports only represent a small number of actual problems experienced by Zicam users. It is generally accepted with prescription medications that reported adverse effects typically only represent between 1% and 10% of all occurrences. However, with an over-the-counter product like Zicam, which is not used under a doctor’s direction, the 130 reports likely only represent a fraction of 1% of the number of users who experienced Zicam smell problems.

ZICAM RECALL LAWYERS

Matrixx Initiatives, the manufacturer of Zicam, was aware of the reported problems were users suffered loss of smell or taste after using their product, but they failed to take steps to protect consumers or adequately warn about this potential side effect.

The attorneys at Saiontz & Kirk, P.A. are reviewing potential claims throughout the United States for individuals who have suffered permanent and severe loss of smell or taste, to determine if financial compensation may be available through a Zicam lawsuit. To review a potential case, request a free consultation and claim evaluation.

49 Comments • Add Your Comments

  • Melanie says:

    After seeing the story about Mary Ann Brandon’s loss of smell because of the product Zicam on GMA I realized the connection between my 13 year old daughter’s loss of smell and her use of Zicam. My daughter has had a CAT scan, an MRI and other testing to find a cause of her loss of smell. Her Otolaryngologist says that it is very unusual for a child to loose their sense of smell and that it is possible that it could have been caused by the use of Zicam. What can we do to make sure this product is not marketed anymore?

    Posted on June 17, 2009 at 10:30 am

  • Tom says:

    I am a 65 yr. old male who has used Zicam for several yrs. I have noticed a decrease in my sence of smell and taste. I assumed it was a simptom of ageing.

    Posted on June 20, 2009 at 2:06 pm

  • Nickelle says:

    I was also using Zicam, but stopped when it starting causing a burning sensation when I used the Cold Remedy Brand.. I lost my sense of smell which has never fully returned but thought it was due to Sinusitis. It’s not until I heard about Mrs. Brandon’s loss of smell that I put two and two together, and realized it was the Zicam that caused the loss of smell. I wish I would have known this before, because if the package would have stated any side effect like this may occur, I probably would have never taken it. Now I just pray that the Doctor’s can do something to get my full sense of smell back…

    Posted on July 2, 2009 at 9:48 pm

  • kelly says:

    I am angry that they have recalled this product. I used it with great success and with no side effects. I was never able to take it orally because of other side effects. My suggestion would be to put a warning on the packaging and return it to the market. That way those that had no issues can continue to use it.

    Posted on July 8, 2009 at 2:16 pm

  • Kathy says:

    I used the Zicam Swabs because I thought I had a cold and it made the whole inside of my mouth and tongue numb for a month.

    Posted on July 9, 2009 at 7:44 pm

  • Robin says:

    I have been using zicam for years. Because of health issues I can not take over the counter cold meds. I swear by zicam. My 3 children and my husband all use it. We have not had any problems. Early on I learned if you put Zicam up to high in your nose it does burn. That is not how it is to be used. If you use it correctly there isn’t a problem. I think people are lazy and not reading the directions before they use it. Please bring it back.

    Posted on July 27, 2009 at 11:29 pm

  • monique says:

    A little over a year ago i got a severe cold and started using Zicam products. I was under the impression it would help your cold. I lost my smell and went to numerous doctors to find out why? They did some test and couldnt figure out why this happend, then i seen the Zicam recall and realized this is what caused it. Im upset Im 28 and cant even smell a fire if I need to!! I wish Zicam could have warned people befor using this product. I would have never used it!

    Posted on August 17, 2009 at 3:07 pm

  • Elizabeth says:

    I believe zicam should be removed from the market

    Posted on August 19, 2009 at 3:43 pm

  • amy says:

    2 years ago my mom lost her sense of smell and had been told by her doctor she had suffered a “mini stroke” in the part of her brain that controls “smell”. She had suspected the Zicam Nasal Spray. (Now we know…) Her loss of smell lasted several months.
    I, my husband and kiddos all use the Zicam gel swabs. I never used the Zicam gel spray after that happened to her. BUT, I have great success with the swabs. We caught a cold this week and really were bummed to go to the store only to find NO Zicam cold swabs… Okay, They definitely need to get rid of the Zicam gel spray. It goes too far up into the nasal cavity. But, the swabs, when use as directed, are wonderful. This product absolutely reduces the druation of our colds. I have not seen as much success in the other Zicam products…so please BRING back the Zicam cold swabs!! People, stop jamming them up your nose. Use as directed.

    Posted on September 9, 2009 at 6:47 pm

  • Ryan says:

    I have used Zicam and I never recieved any side effects of this product (loss sense of smell) and I keep on using this product.

    Posted on September 20, 2009 at 2:25 pm

  • Laura says:

    I also am sorry to see the Zicam cold swabs off the market. My family used them with great results in stopping a cold or greatily reducing the length and severity of a cold. I would like to see them back on the market.

    Posted on September 25, 2009 at 2:26 am

  • Kevin says:

    I really loved the swabs and they were the best thing in stopping a cold in the begining. I think there is too much legal mess in this country now that stops a lot of good products. Just put a warning on it and go from there. Let me know when it comes back on the market and I will buy a ton of them incase the goof balls come back out of the wood work

    Posted on October 5, 2009 at 1:57 pm

  • John says:

    Almost 1 billion doses and the FDA has 100+ complaints?

    I’m sorry to those whose sense of smell has been affected, but there is plenty of evidence to suggest that the severe cold was the cause, NOT Zicam.

    Zicam works for millions of people and now the rest of us lose a valuable resource because some lawyers figured they could make a few bucks off the company.

    Ridiculous.

    I agree, put a warning on the box and put it back on the market.

    Posted on October 9, 2009 at 8:00 pm

  • Rodger says:

    I am a 53 year old man. I used Zicam 7 years ago and have lost my smell and only have about 10% of my taste. I used the product AS IT INDICATED ON THE LABEL. I did not put it too high in my nose. I did not have any severe cold before loss of smell. The ingredient in the product (Zinc) has been shown to diminish your sense of smell/taste in some individuals. After several CT scans and MRI’s….my sense of smell/taste are GONE!. I do taste bitter tastes and some items with butter in them..otherwise everything has no taste. Smell in completely gone. Eating is now for fuel purposes only..NO ENJOYMENT..SUCKS!

    Posted on October 21, 2009 at 1:01 pm

  • Mark says:

    I use Zicam, even today. Yes, today. I had some saved up and it works for me without the side effects others claim. I wonder if others are using something else alongside of Zicam that could be causing this problem.

    I love this product because it is EFFECTIVE at minimizing symptoms and shortening the duration of the cold.

    I’m trying the RapidMelts now to see if they are as effective. They are good, but I think they take a little longer to kick in.

    I want the Nasal Gel back on the market!

    Thank you!

    Posted on October 22, 2009 at 4:17 pm

  • Robin says:

    LOVE ZICAM !!!! have not had a bad cold since i’ve been using it (5-6 yrs) BRING IT BACK !!!!!!!!!

    Posted on November 2, 2009 at 1:01 pm

  • Anita says:

    I’ve used this product successfully for years–with no issues whatsover!

    Bring it back.

    Posted on November 4, 2009 at 5:46 pm

  • richard k says:

    I’ve used XiCam nasal swabs for years. I swear by their effectiveness and they are a CURE for the common cold and flu. So I’m healthy as other people around me suffer like dogs.

    This is a situation where lawyers and nanny-states are screwing everything up for us normal intelligent people.

    Put a label on the box and let me make the decision as to the risk of using XiCam. Even if I lost my sense of smell, I’d prefer that than being bedridden and LOSING MY BUSINESS because I can’t go to work.

    Posted on November 10, 2009 at 12:40 am

  • Lindsey B says:

    I am very sad that I can no longer buy the Zicam nasal swabs. I have never experienced any negative side-affects, just fast recovery from a cold. I love the product and am suffering a cold right now, wishing I had it. (nasal swabs work better then any of the other products) Not everybody experiences the same symptoms (loss of smell and taste) but it is a shame that we all must suffer the consequences. 130 cases seems like a small percentage to me. I agree with the use of warning labels; that’s why we have them. Cigarettes are still here with warning labels, and they kill people. But we all have have to suffer the full duration of a cold with all its inconveniences because a minor number people lost their sense of smell and taste?

    Posted on December 14, 2009 at 8:22 pm

  • Karen says:

    LOVE zicam nasal swabs. Other forms give me lousy side effects, but the nasal spray and swabs worked wonders. Please bring it back!!

    Posted on December 26, 2009 at 10:10 am

  • Lyle says:

    I have been using Zicam Nasal Gel for 3 years, with no side affects!!!!!!!! Great stuff !!!!!!!!!!! I think people are sue happy and the lawyers need money… the makers of the other worthless cold meds are behind getting this wonderful product off the market because it actually works!!!!!!!!!!!!!! I have had a cold now going on 2 weeks, with ZICAM Nasal Gel it would have been gone in 3 days… Please bring it back….

    Posted on December 26, 2009 at 11:43 am

  • jeff says:

    i have used the zicam nasal swab since inception. never had a problem and it is amazing how it controls the onset of a cold. very disappointed that it is off the market. drug compoanies must not be happy with it’s performance…..where can we get the swabs???
    overseas???
    must find out where to buy…do not want to be without it..does anyone know where we can still get the nasal swabs?????

    Posted on December 27, 2009 at 10:43 pm

  • Anonymous says:

    I have used Zicam Nasal Gel for years and have never had a problem — unless you call never having a bad cold again a problem. I’m one of those people who will usually get a sinus infection after a cold. Therefore, stopping a cold is very important to me. The nasal swabs were literally like magic for me. I liked them also because the Zicam products you take by mouth are not as convenient and can make my stomach upset. In my opinion, the FDA should start focusing on taking products off the market that are actually DANGEROUS, like cigarettes, and leave my Zicam alone. All you have to do is read some of the comments here, and you will see that the people who claim they “lost their sense of smell” sound like hypochondriacs. BRING IT BACK!!!

    Posted on January 1, 2010 at 7:04 pm

  • Rick says:

    I suffered a mini-stroke two years ago. I had a cold coming on and administered the nasal spray, “Immediately after I sprayed it into each nostril I felt the most horrific burning sensation. It literally felt like I had sprayed pepper spray directly into my brain. It burned all the way to the top of my skull. My nasal passages swelled, my eyes watered – the burning lasted all night long into the next day.”

    Feeling really weird I went into work and when I went to speak to my co-workers my words were muffled. Upon looking in the mirror I had all the symptoms of a stroke.

    I told the ER doctors what I had taken the night before and they dismissed it, but it was aways in the back of my mind that the Zicam might of been the cause. I was 38 at the time this all took place and it took me a year to recover smell, speech, and motor skills fully.

    Oddly, I feel somewhat relieved other people have had similar experiences with this product. I believe it wasn’t a coincidence.

    Posted on January 4, 2010 at 10:07 am

  • stuart says:

    I started using zicam cold remedy swabs at around christmas time. I had a box on my medicine shelf that I had purchased last winter. I used approximately 8 or 9 doses over the past two weeks. I began to notice a strange smell sensation and my foods began to taste very bland. I began to wonder if this strange sensation had anything to do with the cold remedy that I had taken. I searched the information that is contained in the box and found so side effect warnings that could be associated with my symptoms.

    I want on the internet to check and see if anyone else had experienced these same effects after using the product. I was shocked to find that the product was already in “recall” be the FDA. I had no idea. Now I am very concerned that my loss of smell and taste could actually be more that temporary.

    I still retain the remaining swabs and the box that includes the lot number and expiration date.

    Posted on January 10, 2010 at 8:54 am

  • Dorene says:

    I have been using Zicam for3 yrs. now and have no problems with this product. I put a tiny bit of gel on the side of each nostril like it directs you to do , pinch nose for 5 secs and then wait for 30 secs and blow nose. Even though I have no problem I am getting nervous about using this product again. Its too bad cause it worked for me and I don’t think I should take anymore chances.

    Posted on January 13, 2010 at 9:53 am

  • Ginger says:

    I continue to be an avid supporter of Zicam gel swabs. I would like to see the results of a study done of those 130 cases impacted by loss of smell on whether or not they have an allergy or unusual sensitivity to Zinc in general. In which case, they should not have been using the product to begin with.

    I never experienced a burning sensation or any negative side effects from the use of this product and loved that it was natural and actually worked to reduce the duration and severity of colds. How many thousands or millions of others have had positive results vs the small number impacted?? Put a warning label on the product for those limited few who have problems with Zinc and stop allowing greedy lawyers and big pharma to ruin a good thing for the rest of us!

    Posted on January 18, 2010 at 12:34 pm

  • Blaine says:

    I have used Zicam nasal over the past several years. I used to fly a lot and I found if I swabbed at my destination I VERY rarely got sick from the flight. So many people fly when they are sick, and to be in a confined area for a long time, passengers will get sick from others. I used the product as directed and have always had great success when I did catch a cold. I wish the FDA would leave the ‘homeopathic’
    treatments alone. Sure seems the red tape, hoops and hurdles could be diminished if the consumer would consent to signing a waiver and acknowledgment of risks.

    Posted on February 2, 2010 at 10:25 am

  • Di says:

    I used Zicam spray alot. Anybody that uses nasal sprays and such, or people that just get a cold can lose their sense of smell. With all the more people (130) complaining to the FDA, it’s still a lot less of a percentage (less than 1%) affected than FDA approved (prescription drugs)products. They allow between 1-10%. People are just looking for something to sue about.

    Posted on February 3, 2010 at 7:06 pm

  • Jean says:

    Folks, people react differently to different things. I used Zycam twice and lost most of my sense of smell. I used it properly, I read the directions. I had no idea that I was risking my health but Matrixx did. They had over 800 complaints that they never turned over to the FDA.
    I wish you COULD use the product again with a warning lable attached, but the people who lost all pleasure in eating and lost one of nature’s warning systems aren’t “goof balls” for objecting. I can eat peanuts without an allegic reaction: does that mean they are good for everyone if they are no trouble to me? I’ll bet if it caused blindness for a few people you wouldn’t be demanding to resume taking it.

    Posted on February 11, 2010 at 5:38 pm

  • Susan says:

    I have used Zicam nasal spray for 5 or 6 years and I swear by it. Whenever I feel like I am getting a cold I use it. Yes it does burn your nose somewhat but that goes away after a few minutes and it sure beats getting a cold. I would like to buy more. I still have a little left and I cherish it. Does anyone know where you can buy some?

    Posted on February 11, 2010 at 9:27 pm

  • Blake says:

    I used Zicam nasal spray gel twice, 10 days ago, and although my nasal passages are clear,I have no sense of smell and very little (5%)sense of taste. Like the other folks who suffer from this, not being able to taste foods, or smell dangerous odors, or smoke is a very , very serious condition as far as Im concerned.I NEVER would have taken this product had I known about the pontential side effects. I also firmly believe that anyone who insists on bringing the nasal spray gel back to help fight cold symptons, would never feel that way if they have experiinced a complete loss of smell & tast as I have.It is a BIG DEAL!

    Posted on March 9, 2010 at 11:04 pm

  • John says:

    I used Zicam for years with great results. After trying the nasal spray last November I lost my sence of smell & taste. It has not returned. I swore by Zicam but I do believe people should be warned that using the nasal spray or gel can cause loss of smell & taste.

    Posted on August 13, 2010 at 4:03 pm

  • Doug says:

    I wish I could get the nasal gel back also. Things I did notice are this. This product must be used properly and responsibly. as with anything else, this product must be used in moderation. I inadvertently used the gel and a nasal steriod in the same time frame. Do not use Xicam with any other nasal product. My nasal cavity was dry pocket sore for days. This product should be used sparingly and in the base of the nose only. I did find that I would sniffle and that would allow the gel to move into the sinus’s. You had best blow your nose as the resulting drainage would irritate the back of the throat. The Xicam Melt tabs work fairly well and I have used them effectively, once in the morning and again in the evening. Great product, lets hope they clear up any problems with people that are sensitive to the product.

    Posted on September 27, 2010 at 4:02 pm

  • Dennis says:

    Zicam swabs worked great for us, with no side efects. We want it back. MAYBE it could be packaged with a UMBRELLA LIKE devise behind the swab,, that would open when extracted from the tube. That would keep people from shoving it clear to their eyeballs. Those that would be prone to getting the whole thing stuck in their nose, should have a responsible caregiver. THIS IS MY OPINION.

    Posted on October 14, 2010 at 8:23 pm

  • Ruth says:

    I am going to miss the swabs…I believe they helped me…the spray burns if you have a cold and the “under the tongue” little pills take my sense of taste away for about 24 hours. So, the swabs..I wish would come back..

    Posted on December 3, 2010 at 7:31 pm

  • Linda says:

    As a nurse, I empathize with all who have partially or totally lost your sense of smell as a result of using a Zicam product. I understand the devastating effect this can have on one’s life because I lost my sense of taste and smell as a result of using Zicam’s cough drops. I take offense to anyone who believes I am a hypochondriac or who thinks this occurred as a result of negligence on my part. Just because a person does not experience a side effect from a medication does not mean it doesn’t exist. There needs to be a warning on the medication’s label informing us of the possible risks associated with using the product.

    Posted on December 20, 2010 at 2:58 pm

  • Robert says:

    I used Zicam Nasal Spray for cold symptoms in 2006. That same year I lost about 98% of my sesnse of smell. I went to an Ear, Nose and Throat specialist and he could not tell me why.He stated that my sense of smell may come back, but, it never has. I has been only recently after reading about Zicam causing sell loss did I make the connection.

    Posted on December 27, 2010 at 5:22 pm

  • Susan says:

    I currently am recovering from bronchitis and a sinus infection. I searched for the side effects of zicam nasal gel because after using it today my sinus cleared but I cannot smell or taste anything except a bitter saliva that no amount of brushing or mouthwash can clear. I even sprayed my favorite perfume, Nothing!
    I pray that my senses return. It is scarey to think that I may never enjoy the aroma of home cooking or a pot of coffee brewing.
    There was no warning. I read everything before use!

    Posted on January 8, 2012 at 6:36 pm

  • Arlene says:

    Please bring back Zicam nose swabs, I use it when I feel a cold coming on and I have not had a cold in about six years. People do lose their sense of taste and smell during a cold, why is Zicam being blamed for this.

    Posted on January 18, 2012 at 9:19 am

  • Michael says:

    I think the ban on Zycam Cold Swabs is uncalled for. The FDA allows many drugs on the market that have severe side effect some even possibly fatal. Very few people have had these side effects with Zycam and none have been linked to a fatality. Why are they being so hard on Zycam Cold Swabs? A warning on the label may be called for but, a recall is just a little overboard if you ask me, maybe even unfair.

    Posted on February 14, 2012 at 2:14 am

  • Michelle says:

    I’m betting the majority of the people who “suffered” a loss of smell DID NOT READ THE INSTRUCTIONS COMPLETELY. One squirt in each nostril, pinch nose together for however many seconds, DO NOT SNIFF THE ZICAM UP YOUR NOSE and do not blow your nose for 30 minutes. If you used it properly you can see clearly it came nowhere near your nasal cavity unless you immediately sniffed if because it was running out of your nose. You were supposed to only dab with a tissue whatever Zicam was leaking out. I really don’t want to hear a bunch of people who I know didn’t follow the instruction to a T. How else would the Zicam get to your nasal cavity?? So thanks a lot for taking an EXCELLENT product off the market. It’s a real joy to sit here and watch my daughter suffer with a horrible cold she caught and not be able to do anything but give her drugs instead of something natural to speed up the healing process.

    Posted on April 14, 2012 at 1:40 am

  • Grant says:

    Zicam Cold Remedy Nasal Gel was the only medicine over the counter you could buy that would actually end a cold overnight. I think that is the real reason the FDA pulled it. Because of these tiny amount of crybaby’s that say they lost their sense of smell put together with these lawyers, the rest of us that know better have to put up with a cold again…
    SAD

    Posted on September 8, 2012 at 7:56 pm

  • Jessica says:

    I have used zicam for many years and have had good luck with it. I would be upset if it was not available to me anymore. This seems to be a hard time with the economy and all and if we all think about it, when you get a cold….you cant smell or taste things as well. I think this is a case of $$$$$. Pretty sad. I hope this is straightened out. I guess I will just take zinc tablets and suffer from “loss of smell and taste” RELATED TO A BAD COLD BECAUSE I COULDNT TAKE ZICAM because of some silly people who need to ruffle feathers to make a buck.
    SO SO SAD!!!

    Posted on September 14, 2012 at 7:00 pm

  • james says:

    the use of zicam nasel spray has become qiet costly>2 trips to hospital
    plus anti-biotics,fuel,discomfort…at 75 the product is very dangerous although it seemed to work but am now on multible anti-biotics and
    praying i can overcome this sickness.

    Posted on December 28, 2012 at 11:15 am

  • Mary says:

    I used 2 zicam pills and now the right side of the roof of my mouth is numb. I will not be using zicam anymore and will spread the word about it.

    Posted on January 12, 2013 at 9:00 pm

  • Don says:

    The loss of taste is the least of my problems after using the rapidmelt version. My tongue is numb 6 days after the last use. It’s very hard to chew food and I now have a speech impediment that isn’t showing any signs of improving.

    Posted on December 16, 2013 at 5:12 pm

  • Candy says:

    Zicam oral spray worked well for me. Then a couple of months ago I tried the rapid melts and I have a metal taste on my tongue that is gross and won’t subside. Wish I knew how to get rid of this. I did not use this product incorrectly. Seems like enough people have been affected that it should matter.

    Posted on April 4, 2014 at 11:21 pm

  • Douglas says:

    Used the swabs….immediately experienced burning sensation. Within a day I my sense of smell AND taste was affected. After a week….specialist , MRI, CT scan were ordered. I suffered for THREE YEARS with this. I wish nothing …..but to have the CEO of Mattrix experience what I have been through. If it weren’t for continued use of supplements to overcome this ……I’m not sure the outcome would have been positive. This company does not deserve to remain in business. Their lawyers lied and this company got off ….cents on the dollar. End users like myself were the big losers,

    Posted on January 28, 2019 at 10:28 pm

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