Mylicon Recall: Infants’ Gas Relief Drops Could Contain Metal Fragments

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By: AboutLawsuits | Published: November 11th, 2008

Approximately 12,000 plastic 1 ounce bottles of Infants’ Mylicon Gas Relief Dye-Free Drops (simethicone-antigas) sold since October 5, 2008 have been recalled after it was discovered that some of the bottles could contain metal fragments.

Mylicon gas relief drops are manufactured by Johnson & Johnson-Merck Consumer Pharmaceuticals Co., which is a joint venture between Merck and Johnson & Johnson to market non-prescription products derived from Merck prescription medications.

Infants’ Mylicon is an over-the-counter anti-gas medicine, which is used to relieve the discomfort commonly caused by infants swallowing air or from certain formulas and foods.

Consumers have been urged to immediately stop using any 1 oz plastic bottles of dye-free Mylicon infant drops with lot numbers SMF007 or SMF008, which can be found on the bottom of the box the product came in, or on the lower left side of the sticker on the bottle. The recall applies to products labeled “Infants Mylicon Gas Relief Dye Free Non-Staining Drops 1 oz.” with expiration dates of 09/10.

The Mylicon gas relief drops recall was issued as a precaution because some bottles could contain metal fragments that were generated during the manufacturing process.

In a press release announcing the Mylicon recall, Johnson & Johnson indicated that “the potential for serious medical events is low”, and that if any problems do occur, it is expected that they will be temporary and resolve without medical treatment. However, parents who have given the product to their infant should contact their healthcare provider immediately if they are concerned.

The recall only applies to 1 ounce dye-free Mylicon gas relief drops. Original Infants’ Mylicon Gas Relief products, which are available in 1/2 oz. and 1 oz. sizes, as well as Infants’ Mylicon Gas Relief Dye Free drops non-staining sold in 1/2 oz. sizes, have not been recalled and there is no indication that they may contain metal fragments.

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There Are 40 Comments So Far • (Add Your Comments)

  1. this is ridiculous! for some babies this is their only relief! my son’s formula has been switched 3 times and Mylicon is the only thing that gives him relief. Not only is this type of neglect not fair to the babies but also the parents who are paying $15 per once for this product. More caution needs to be taken when manufacturing children’s medicine.

  2. I am extremely upset!! How long has Johnson & Johnson known about this??? Since October 5, my Grandson has used several 1 oz. bottles. How many peolpe save bottles after the medication is used? I do not know what those lot numbers were!!! According to Johnson & Johnson, “the potential for serious medical events is low and if any problems do occur, it is expected that they will be temporary and resolve without treatment”. This basically tells me that J & J does not know the extent of medical difficulties that can occur through their carelessness.

    Grandma

  3. My 3 month old little girl HAS to have Mylicon after each feeding for her very sensitive stomach. Lately, she has begun throwing up excessively after eating and taking the mylicon. It never occurred to me that it could be the mylicon, but now I am wondering if that is what has caused her to throw up???

  4. First it was the peanut butter which my daugher who is now 3 was ill for several days after she ingested it, and now this. My infant was born October 4, 2008 and at my hospital they had sent letters out saying that the medical equipment used for surgeries and obsterics were not autoclaved ( the sterilization process after cleaning). We have been nervous since then and now this. I have used these drops since her birth, and I do not keep the bottles. This is ludicrous and negligent to say the least. If metal fragments are in the products that tells me that the machinery used to house the drops is not undergoing mandatory maintenance. Such a shame. Johnson & Johnson is a OLD company and the 2nd largest billion dollar company. This is embarassing for the US to say the least. Very angry parent.

  5. Just wanted to remind you that the Mylicon recall is only for the dye-free version of the product and only the 1 oz. version. So, you can still buy the product if you need it without fear in the 1/2 oz. versions OR in the regular, not dye-free versions. So, don’t worry, the babies can still be relieved. Also, simethicone, the ingredient in the product is available in other name brands and non name brands such as Equate from Wal-Mart and the Walgreens brand. Simethicone is all the same and the off-brands are a lot cheaper. The Equate version is 1/2 the price of Mylicon and EXACTLY the same medication. That’s what I use…

  6. We’ve been using Little Tummies for over a year with our toddler and have seen the same relief provided as what Mylicon offers…for much cheaper. I’d say switch to Little Tummies and stop using Mylicon with or without the recall…

  7. This is ridiculous! Especially for a highly trusted company like Johnson & Johnson. The bottle says “Safe for every feeding”. Lies!

  8. This is totally outrageous. J & J should be fined for this.. It would also be nice if J & J would share what type of metals seemed to have been dropped into the Mylicon which both of my children have used… it better not be lead.

  9. I use mylicon with my son also. I was very upset to hear about this. J&J should have kept a closer eye on this.

    Carley, you may want to take your little girl in to the pediatrician office. she may have reflux is she is throwing up excessively or it may be the formula, you may want to check with your pediatrician and see if a formula change will help. My son who is 11wks old we just found out he has reflux and a slow emptying stomach which is causing his excessive throwing up. My 2 yr old also had the same trouble.

    this doesn’t excuse J&J and i’m not making any excuses for them.

  10. Okay seriously I am sure that this is Johnson and Johnson being overly cautious as well… neglegent would be if they didn’t give everyone this fair warning I’m sure all of your children are fine. Things like this probably happen all of the time in factories and no one even knows. If you have already used the bottle and your child is okay it doesn’t matter that you don’t have the bottle still. Mylicon is a great product and has probably helped many of u and your children get sleep at night and I don’t think this means you should stop using it!

  11. This is crazy. Does J&J realize that they are messing with our babies health. I’ve been giving my son this crap for the last 4 months (since birth). I can’t even count how many bottles I’ve gone through. J&J YOU SUCK. Plain and simple. Thanks for nothing.

  12. Wow Mylicon is pretty vague about what can happen as a result of taking the Mylicon with metal fragments. Stating that “serious medical effects are low, if any” isn’tgood enough. What are the medical effects? My granddaughter has been on Mylicon much since she was about 2 weeks old. She’s now approaching 10 weeks and we don’t have the empty bottles to look at the stock numbers. All we do know is lately she’s been having screaming fits….could they be related?
    Mylicon needs to step up and put out what the side effects could be and how much has to be ingested before they set in, etc. Also since this effects infants/babies they need to be more precautionary and pull all their medicine and present more facts.

  13. this is ridiculous my daughter has had 2 one ounce bottles of mylicon since the beginning of september i didnt keep the bottles who would after they are empty? now i have to throw away the bottle i just opened i cant give that to her with the thought in the back of my mind that there still could be something in it! this mistake should have been caught and told about a lot sooner than it has been.

  14. I also have been using these since my girl born October 6th, 2008 was born, we started using them maybe a week or two after having her and ever since then she has had digestive problems, she has nearly no bowel movements, her stomach is hard and bloated, she is in very much pain and screams non stop for hours….. my doctor could not figure out what was wrong so we went to a GI specialist and he gave us a laxative medicine that has done nothing… could this be related to the drops? I was using them up until yesterday when i heard.

  15. For all the whining going on here, has anyone actually linked a single adverse effect to this metal issue? Kudos, actually, to J&J-Merck for recognizing the problem and alerting the public. If you want manufacturers to be held to the standard of perfection, as so many of you do, you’ll quickly find that no one will want to manufacture products (or sell them in the U.S…where lawsuits are rife) that might actually HELP your child’s symptoms and problems.

  16. What is so sad about this is it isn’t just J&J who are putting Americans at risk, It is the food we eat the vaccinations we get its everything now a days what a shame =(

  17. My grandson of 3 months was admitted to the hospital 3 times in the month of November. The last admission is when the dr. discovered my daughter was giving him mylicon drops for his gas. His formula was changed and the mylicon drops were discontinued. He was discharged on Nov. 18, 2008. He is feeling better but I wonder what kind of metal and has it already caused him problems??
    This makes you wonder if this is making our babies sick what are other medications doing to our adults????

  18. I have a 3 week old that i give mylicon all the time! She has started throwing up more often and i think it is the mylicon! She is not a fussy baby and here lately she has been crying for no apparent reason! I am wondering if this has to do with the fragments of metal that were found? I am very upset about this!

  19. This is unbelievable! I put my son on these when he was 2 weeks old. He is such a good baby. He never cried or fussed over anything unless he was hungry but after about a week of being on these drops he started crying all the time and having belly aches. I’ve had him off the drops since the recall but he still spits up all of his milk and keeps his legs drawed up like he’s in pain. When I called his Dr. after I called the company the dr, refused to see him and said he would be ok. But I can tell that he has just not been the same since. Makes you wonder if theres anything out there you can ever trust to give your kids. I will never use another j&j product again.

  20. This is uncalled for. my son needs this med. He has used it since he was 2 months old. He has had his formula switched 4 times he is now 6 months old. They found a formula that doesnt make him sick of bleed from his intestines and its 50 dollars a can, almost 1000 dollars a month. And my husband makes 26 dollars more then allowed for assistance. But that income is based on someone that has normal formula that is the cost of 10-15 dollars a can. But he has to have this formula its the only think that works. And it makes him very gasy, there for he needs this meds to be able to stay calm. And now i cant use it. Now all my son does is scream and cry pretty much all day cause he is in pain. He only sleeps about 4 hours A DAY now, which is not good since he is suppose to sleep anywhere from 10-14hrs a day. There for my husband and i get no sleep either. I think JJ should be very disapointed in there selves. They should take better percautions with there products seeing how its for Babies and Childern. They must not care very much. Not to mention that like the other person stated, I dont keep the empty bottles how am i suppose to know if he took in bad bottles. he has went threw atleast 2 a month since july. I want to know what medical risk my child is maybe going to get or has got or going threw and no one knows about now. This could be the reason behind a lot of my sons medical problems that he has had since he was 2 months old. This is really upsetting.

  21. My daughter is now 5 months, I experience some of the same issuse as most of the parents, from formula changes, and finally the doctor said that she has refulx and put her on a lasctose-free formula, but in the beginning she used to cry for hour so i started giving her the recommend Infant Mylicon drops at 5 days old.. then she was having trouble breathing and thowing up alot. I never heard any NEWS flash recalls even as of today, I happen to read about this in PARENTS MAGIANE today.

    How could they even sit there and say the effect may be low, or go away without medical treatment..We are resopnable for our kids.Yet I feel that J&J should also be responable too.

  22. this is so rediculous if the Mylicon has been recalled why the hell is the stores still selling it i just bought some last week and my 9 month old has been using it since she was 3 months old and i am just now hearing about this recall i am ferious i swear i will sue if i find out that why my child has been breaking out!!!!!!!!!!
    Very Angry Parent

  23. this really dosent make any sense because they still sell it in the stores and my baby boy was 2 months and he died from this medicine when i give it to him he would spit up alot and act strange out of the blue the last time i gave my baby the medicine and he didnt wake up when he went to sleep

  24. I´m very concerned and angry! I just bought the medicin (2009), and also just heard of the recall! What the hell is wrong with J&J!!!!
    I´m so afraid, just read Kimberly’s post, what should I do?

  25. Why si this product on the shelf. I have twin boys- 3 1/2 months old & just gave mylicon to them & now i come across this. How come I’m just learning about this like many others?This is unexcusable.

  26. little tummies does not work!

  27. I’v been using mylicon since my baby boy was born on may 30,2010 and had know clue that mylicon was recalled and was able to buy the product from walgreens and cvs in the florida area till just recently and ask a pharmacyst how come there know longer availible and he had know clue and i think that this is a out rage and i pray there is nothing wrong with my little one and johnson and johnson are at fault and need to be recond with.

  28. I m very upset that my daughter has been taking this since she was born Feb. 2010, and I am just now hearing about this recall!!!!! I don’t know what to do, and why am I still able to buy Mylicon???? This is ridiculous!!! Please be more careful with baby products, and when a product is contaminated, please make it more well known!!! We as parents try so hard to take care of our children and only give them the best, and now I learn that I ve been giving her unsafe medicine for 7 months!!!

  29. well i’m pissed just like kimberly my 5 week old daughter was spitting up alot after using product and last time i gave it to her she didn’t wake up WHAT IS J&J GOING TO DO TO FIX OUR BROKEN HEARTS HOW WILL THEY GIVE ME BACK MY BABY?????????????????????????
    MY LIFE??????????????? WHERE DO I GO NOW????????? HELP??????????????????????

  30. I am absolutley furious. My 4 month old son has been using Mylicon since he was born. He would always cry and be uncomfortable but I have noticed since we stopped using the product he is getting better. Could this be because of the mylicon but Johnson and Johnson has no idea obviously what the side effects even are. I am thinking of a lawsuit.

  31. I cannot believe this. I am beginning to wonder could this be the cause of my sons stomache problems?.

  32. I have also given my 2 month old this product, and she has also vomited after I gave it to her. I am very surprised! You give your child medication to help them, and it reverses and ends up hurting them. What the Hell! Then, the price is expensive, but as a parent you don’t mind buying it because you are under the impression that it will help. Ugh! I am very angry Parent! I had no Clue this was taking place until someone informed me of the recall, and the dumb store (CVS) sold it to me.

  33. 2010 INSTEAD OF MYLICON WORKING IT UPSET MY BABIES TUMMY EVEN MORE!!! NEVER AGAIN WILL I BUY YOUR PRODUCT SHE IS CRYIN LIKE SHE HAS COLIC!!!! IM VERY UPSET!! THANKS ALOT STUPID MYLICON!!! WHEN MAKING CHILDRENS MEDICINES YALL SHOULD PERSONALLY FILL THE CONTAINERS!!!! WOW!!! MAKING PARENTS HAVING HARDER TIMES HANDLING THEIR CHILDREN.

  34. Okay, if the bottle is the problem, they should inspect the bottle. Or change the bottle and continue to sell it but, it needs to be tested before getting back out on the shelves. My son Cadence has used this medicine since he was first born. He is currently 14 months old now. If this medicine was doing all this, why didn’t they recall it a long time ago? MYLICON GET IT TOGETHER OUR CHILDREN NEED THIS MEDICINE!

  35. Why has Mylicon even kept this crap on the shelves if it is making infants pass away, vomit, cry and make them feel worse? Sorry Mylicon but, you cant turn this one around. GOOD JOB DUMBASSES

  36. I have been using the off-brands of Mylicon for 2 years and haven’t had any problems. Just for all you Moms out there with little ones that have major digestive problems…We found that our son has a gluten allergy. He had awful colic when he was an infant, and broke out into rashes when we went from rice cereal to oatmeal when he was 6mo. He was an awful sleeper and was either throwing up or had serious constipation. The biggest advice I can give you other Moms out there is: FLAX OIL! I added 2 tsps to his cereal in the morning for 2 months and he went back to a regular BM schedule after the first day! When he was 16mo we discovered the gluten allergy. Now he is much better and happier. I suggest to any Mom who has a small one with cronic constipation to try a gluten-free diet and add Flax Oil to purees to get them back on track. Good luck!

  37. I am so sorry to hear about all your babies problems with using this medication…I just need to ask a question..Did your pediatricions suggest you use this product or did you just do it on you own? I raised two children and would never think of using any type of medications to releive gas or because they were throwing up..I would ask the dr. what was the best route to take for my baby..Also my babies dr never believed in giving anti-biotics unless it was absolutely necessary…Please talk to your pediatricion on this matter!!!!! I pray that all your babies are safe from any harm from this medication!

  38. I am confused. Is there still a recall on the gas drops? If so why is it still being sold in stores? I had my baby boy Feb.2011 n have been giving him these drops since he was born and I’m just hearing Abt a recall frm 2008? So has the problem been fixed? Or was it fixed and now there’s another recall? I can’t find a straight answer on are the drops safe now or not? The drops have worked great but he has had stomach problems off n on could this be from the drops? I don’t kno know if these drops are the problem or not because I can’t find an answer if in June2011 r the drops safe or not because like I said they do work for his gas right away. Someone please give me an answer

  39. This is sad! When so many parents trust johnson johnson for thier babys,seems some body isn’t doing thier jobs!! johnson johnson should give every one who bought the drops thier money back,I just hope no babys will be hurt from this mess up,I’m a grandparent and my grandson is only three months old and he has been taking the drops since he has came home from the hosp. only seems things have gotten worst for him,all he does is scream with pain in his belly and spits up all the time,would have been nice that johnson johnson would have got the message out for parents to stop the drops,looks like from what all I have been reading the same thing is going on with all the babys who used the drops,My grandchild will never take any thing from johnson johnson ever again even when the recall is over.If enough parents stand thier ground and buy nothing from johnson johnson it will show them we mean bussiness and put thier asses out of bussiness!!! I pissed off grandma!!

  40. And the truth is that now there is no more Mylicon and babies are still getting the symptoms described from everybody above. Hmmm…who do we blame now?

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