Mylanta Recall Issued for Labeling Update

More than 12 million bottles of Mylanta are being recalled by Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. because the label does not warn consumers that the antacid medication contains alcohol.  This is the second recall in one week by a division of Johnson & Johnson over labeling errors, after a Tylenol recall was issued for the same reason on November 24.

The Mylanta recall was announced on November 29 by the FDA and will result in 12 Mylanta liquid products and one AlternaGEL product being recalled at the wholesale and retailer level. Johnson & Johnson-Merck Consumer Pharmaceuticals, which is a joint subsidiary of Merck and Johnson & Johnson, indicate that there is no risk to consumers and people who have purchased Mylanta can continue to use it as normal.

An internal review by the manufacturer found that the label did not indicate that alcohol was an ingredient in the flavoring agents for the medications, resulting in the recall. The company claims that the small amount, less than one percent, is unlikely to cause adverse events related to alcohol absorption or alcohol sensitivity.

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The recall affects about 12.3 million bottles of the following brands:

  • Mylanta Regular Strength Original 12 FL OZ; UPC 716837610120
  • Mylanta Original 5 FL OZ; UPC 716837610557
  • Mylanta Regular Strength Mint 12 FL OZ; UPC 716837629122
  • Mylanta Maximum Strength Cherry 12 FL OZ; UPC 716837622123
  • Mylanta Maximum Strength Mint 12 FL OZ; UPC 716837624127
  • Mylanta Maximum Strength Original 12 FL OZ; UPC 716837652120
  • Mylanta Maximum Strength Original 24 FL OZ; UPC 716837652243
  • Mylanta Ultimate Strength Mint 12 FL OZ; UPC 716837643128
  • Mylanta Ultimate Strength Cherry 12 FL OZ; UPC 716837644125
  • Mylanta Supreme Tasting With Calcium Cherry 12 FL OZ; 716837825128
  • Mylanta Supreme Tasting with Calcium Cherry 24 FL OZ; 716837825241
  • Mylanta Maximum Strength Original 12 FL OZ’ UPC 716837652151
  • AlternaGEL 12 FL OZ; UPC 716837860129

A full list of lot numbers and NDC numbers can be found in the FDA Mylanta recall announcement.

The recall is similar to a Tylenol Cold Multi-Symptom recall announced on November 24 by Johnson & Johnson’s McNeil Consumer Healthcare, which was also issued because the manufacturer failed to inform consumers on the front label that the cold medicine contained alcohol. That recall affected 9 million bottles, and was also conducted only at the retail and wholesale level.

Johnson & Johnson has been under scrutiny since a massive recall on April 30, which affected 40 different liquid medication products, including Tylenol, Benadryl and Motrin. That recall affected 136 million bottles of children’s medications, and resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant, and the suspension of the production of all of McNeil’s children medications.

9 Comments

  • TeshiniaJuly 25, 2022 at 8:55 pm

    I been taking it for years still do

  • TeshiniaJuly 23, 2022 at 11:14 pm

    I take this medics on the regular

  • RalphMay 2, 2012 at 1:39 am

    I can't beleive there was a big problem with Mylanta extrastrength chewagles there were the real deal for me. I have reflux desease and the chewables were the best for me . Who cares if there was a little alcohal in the med's. probably most of the people who filled the law suit drank any way so what's the big deal

  • T. LyJanuary 13, 2012 at 7:36 pm

    I have bought Mylanta in the pass on many occasions. I am looking for it again and I hope they put back on the stores again. I wish they had label right the first time so they and us don't have to go through this. To me, a little alcohol is okay because that is something people have been use for long time. On the other hand if they try to use different type of products that people have never use o[Show More]I have bought Mylanta in the pass on many occasions. I am looking for it again and I hope they put back on the stores again. I wish they had label right the first time so they and us don't have to go through this. To me, a little alcohol is okay because that is something people have been use for long time. On the other hand if they try to use different type of products that people have never use or was never approved then, yes punish them for it. Don't try to just punish company for something minor like this. Soon there will be no one wants to start any business.

  • HarryNovember 7, 2011 at 1:04 am

    Will Mylanta be back in stores? I've been taking it for about 20 years, when I started eating and loving ot wings. Please let us know. Thanks

  • E. sandersMarch 22, 2011 at 3:42 pm

    Will Mylanta be put back in stores in Columbus OH soon.It Help my gas problem.

  • CarolaJanuary 12, 2011 at 6:06 am

    I was very disappointed that I received an e-mail from my daughter. She does the shopping for me and went to WalMart to get Vit. E and Aspirins. I also asked her to purchase two boxes of the Mylanta which she said was recalled. Now I don't see that there is any alchohol in these lozenges and I cannot get out to look for any because I have no transportation.

  • cliffDecember 15, 2010 at 4:01 am

    I have been taking mykanta for years. What alternative is there?

  • Disseminate the TruthDecember 3, 2010 at 7:22 am

    Please file a class action lawsuit! Johnson & Johnson /McNeill Consumer Healthcare is a prime example of corporate corruption, dishonesty and malfeasance. They don’t care one bit about how many people they harm. What may be even worse is the fact that the main media outlets are not reporting the WHOLE story. A TIMELINE OF THE MCNEIL CONSUMER HEALTHCARE / JOHNSON & JOHNSON RECALLS: 200[Show More]Please file a class action lawsuit! Johnson & Johnson /McNeill Consumer Healthcare is a prime example of corporate corruption, dishonesty and malfeasance. They don’t care one bit about how many people they harm. What may be even worse is the fact that the main media outlets are not reporting the WHOLE story. A TIMELINE OF THE MCNEIL CONSUMER HEALTHCARE / JOHNSON & JOHNSON RECALLS: 2008: The so-called “phantom recall” took place, in which Johnson & Johnson allegedly hired contractors to pose as customers and buy a certain type of adult Motrin in order to remove the product from store shelves. November 2009: McNeil recalled five lots of Tylenol Arthritis Pain Caplet 100 count bottles because of an unusual smell or taste. Consumers reported nausea and related symptoms. December 2009: McNeil expanded the November recall to include all lots of Tylenol Arthritis Pain 100 count. January 15, 2010: Johnson & Johnson issued a massive recall of over-the-counter drugs because of a moldy smell that has made people sick. The company determined that the odor was caused by the presence of a chemical called 2,4,6-tribromoanisole (TBA). The FDA said McNeil knew of the problem in early 2008 but made only a limited investigation. Federal regulators criticized the company, saying it didn't respond to the complaints quickly enough, wasn't thorough in how it handled the problem and didn't inform the Food and Drug Administration (FDA) quickly. The recall includes, but is not limited to: • Regular and extra-strength Tylenol • Children’s Tylenol • Tylenol Children’s Meltaways • Tylenol 8 Hour • Tylenol Arthritis • Tylenol PM • Tylenol Extra Strength • Children’s Motrin • Motrin IB • Benadryl • Rolaids Antacid • Simply Sleep products • St. Joseph's aspirin The FDA said about 70 people have been either sickened by the odor — including nausea, stomach pain, vomiting and diarrhea — or noticed it. March 31, 2010 – McNeil recalls Zyrtec Itchy Eye Drops April 30, 2010: McNeil announced that more than 40 types of children’s and infants’ products were voluntarily recalled. Quality issues included the possibility of the medication containing too much of the active ingredient, containing substandard inactive ingredients, or containing tiny particles. The recall included more than 135 million bottles of children’s medication. May 5, 2010: Additional recalls: Tylenol, Motrin, Benadryl and ZYRTEC. The FDA found "serious" problems at the McNeil Consumer Healthcare plant. Raw materials were found to be contaminated with bacteria, but they were used anyway, the agency found. Quality control was lacking. And the company didn't investigate potential manufacturing mess-ups, even after receiving consumer complaints about medicines contaminated with black particles, the report notes. "The findings are serious," FDA official Deborah Autor tells the Washington Post. "Consumers should not use these products." May 6, 2010 - Philadelphia Public Health Examiner: The FDA has charged that McNeil knew the raw material had known contamination with gram negative organisms [bacteria] yet approved it for use to manufacture several lots of Children's and Infant's Tylenol drug products.. . . The FDA also slammed McNeil for its delayed response in handling the presence of a known contaminant in another one of its plants. The products recalled earlier this year were not children's products. The earlier recall was for Rolaids and Tylenol extra Strength and a third Tylenol product. The complaints that led to these recalls did include three adverse events. May 6, 2010 - CNNMoney.com -- The FDA confirmed that the bacteria found at the Johnson & Johnson plant that produced the recalled children's medicines was Burkholderia cepacia. May 28, 2010: Blacksmith Brands, after conferring with the FDA, initiated a voluntary recall of four PediaCare children’s cough and cold products manufactured at the same McNeil Consumer Healthcare plant that was recently shut down because of poor quality manufacturing. Products included in the recall are: • PediaCare Multi-Symptom Cold • PediaCare Long Acting Cough • PediaCare Decongestant • PediaCare Allergy and Cold June 15, 2010: McNeil expanded its Jan. 15, 2010, recall to include five more lots of Benadryl and Tylenol that were “inadvertently omitted from the initial recall action.” Congress announced it would investigate. July 8, 2010: McNeil Consumer Healthcare is now recalling 21 more lots of over-the-counter medicines sold in the U.S., Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago and Jamaica, including: • Benadryl Allergy Ultratab Tablets • Children’s Tylenol Meltaways Bubblegum • Motrin IB Caplets and Tablets • Tylenol Extra Strength, EZ Tablets, Cool Caplets, Day & Night • Tylenol Rapid Release GelCaps, Tylenol 8 Hr, Tylenol Arthritis, Tylenol PM • Tylenol PM Caplets, Geltabs, and Rapid Release Gelcaps • Tylenol, Motrin, Zyrtec, Benadryl Also, five complaints filed in the U.S. District Court for Northern Illinois against McNeil are seeking class-action status. Consumers accused McNeil of fraud and racketeering for not recalling all of its children’s products and for not adequately reimbursing consumers for their out-of-pocket expenses. . The buyers of those recalled meds are demanding cash refunds--rather than coupons for replacement products--in five suits. July 16, 2010 – Jere Beasley Report: Rep. Towns, chairman of the House Committee on Oversight and Government Reform, says Johnson & Johnson has used delaying tactics in its dealings with the committee and in some instances had provided misinformation. . . The FDA has referred the McNeil case to its office of criminal investigation. http://www.jerebeasleyreport.com/2010/07/drug-maker-fails-to cooperate/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+JereBeasleyReport+(Jere+Beasley+Report When will the entire story be exposed? When will J & J be shut down?

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