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You are here: Home / Featured / Certain OTC Infants and Children's Products Recalled, Including Tylenol, Motrin, Zyrtec & Benadryl

Certain OTC Infants and Children's Products Recalled, Including Tylenol, Motrin, Zyrtec & Benadryl

May 2, 2010 By The FDA 15 Comments

McNeil Consumer Healthcare LogoMcNeil Consumer Healthcare is recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children.

McNeil Consumer Healthcare is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm

Below are some of the well-known over-the-counter (OTC) infant and childrens’ brand-name medication affected in this recall:

TYLENOL® INFANTS’ DROPS
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR*
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR
CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE – HOSPITAL
CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE – SAMPLE

CHILDREN’S TYLENOL® SUSPENSIONS
CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR
CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR
CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE
CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL

CHILDREN’S TYLENOL® PLUS SUSPENSIONS
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR
CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR

MOTRIN® INFANTS’ DROPS
CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE
CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR*

CHILDREN’S MOTRIN® SUSPENSIONS
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE
CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE
CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE
CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL

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Filed Under: Featured

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Comments

  1. katie says

    May 7, 2010 at 1:11 pm

    does this recall affect the equate products, such as equate children’s pain relief and equate allergy relief, thanks for any help.

    Reply
  2. Joy says

    May 15, 2010 at 8:48 pm

    I would also like to know if this recall involves Equate Infants Pain Relief Concentrated Suspension Drops Acetaminophen. I bought it about 4 months ago and it expires 12/2011. Please let me know =)

    Reply
  3. serena butler says

    May 26, 2010 at 2:25 pm

    Does the recall involves Equate Infants Pain Relief Concentrated Suspension Drop Acetaminophen, because I have a 9month old and a two year old.

    Reply
  4. TONYA says

    May 26, 2010 at 4:51 pm

    I would like to know does the brand Equate been recalled? What about the brand Healthy accents, and the adult brand Zyrtec 24hr tabs?

    Reply
  5. mary bond says

    May 26, 2010 at 8:00 pm

    I HAVE EQUATE INFANTS PAIN RELIEF, THREE OF THEM:

    LOT NUMBERS:

    9MK0065
    0AK0024 (2 OF THEM)
    LET ME KNOW IF THEY’RE SAFE. I AM NOT HAPPY THAT ABOUT ALL THESE DRUG RECALLS FOR OUR BABIES AND TODDLERS. SINCE I BECAME A PARENT ALMOST 4 YEARS AGO, I THINK EVERY OTHER ITEM I HAVE PURCHASED FOR MY BABIES/TODDLERS HAS BEEN RECALLED INCLUDING CRIBS, CAR SEATS, FORMULAS, AND AN ENDLESS NUMBER OF TOYS FROM CHINA CONTAINING LEAD. IT’S A DISGRACE. YOU SHOULD BE VERY ASHAMED OF YOURSELF FOR PUTTING OUR BABIES IN HARMS WAY.

    Reply
  6. Susie says

    June 4, 2010 at 2:49 am

    I too am curious to know if the equate brands are affected by the tylonel/motrin recall. With an infant and a toddler in the house I too would like the answer to this question that doesn’t seem to be available anywhere.

    Reply
  7. Indu says

    June 17, 2010 at 2:00 pm

    My Pediatrician said it was OK to give the generic brands. That’s what I’ve been using since the recall was announced – The Walgreens or CVS brands are what I’ve been using – both Acetaminophen and Ibuprofen. Pretty sure Equate would be the same since its a Walmart brand

    Reply
  8. yvonne says

    June 20, 2010 at 11:14 pm

    Has anyone gotten an answer yet if equate products are on reecall?? I serious need to know.

    Reply
  9. yvonne says

    June 20, 2010 at 11:16 pm

    my pedi said it was ok.Bullshit. my son has a sever rash & bruising all over..Temp of 104.5 Everyone stop using it asap….Now im in the process of suing the doctor…

    Reply
  10. tearra says

    July 10, 2010 at 6:41 pm

    yeah, so I have read on all these questions about equate and if this recall business if related to it….. a simple yes or no would be great. I guess we aren’t allowed a simple answer from the company. I work in the medical field and this is just sad!

    Reply
  11. Juliet Grossman says

    July 11, 2010 at 5:54 pm

    It has been my experience that Walmart is very responsive and pro-active about removing recalled items from shelves.

    After the Motrin recall I had trouble buying more Motrin (guess they are still working out production problems?) so ended up buying Equate Children’s Ibuprofen liquid (the one that says “Compare to Children’s Motrin” on the box).

    The shelves were very bare because there are so few products available now with all this recall stuff being worked out.

    This is what I found re: recalls on Walmart’s site. They do NOT list the Equate on this list: https://walmartstores.com/Recalls/

    Reply
  12. Robin says

    August 6, 2010 at 11:56 pm

    So is it a yes we can use the Equate pain relief concentrated drpos acetaminophen campare ot concentrated Tylenol? I have some exp date 8/12 lot ODK0043

    Reply
  13. Florida Girl in Sydney says

    August 23, 2010 at 8:20 am

    Tylenol and J&J were a trusted name in our house– never again. There is no reason a company should have this many recalls — they are careless and clearly have no regard for the adults and children they could be damaging.

    Reply
  14. MARY ARRINGTON says

    December 10, 2010 at 12:45 am

    I USE EQUATE ALLERY, LIQUID AND TABLETS, ARE THESE SAFE?

    Reply
  15. Sheree Crites says

    May 18, 2011 at 6:34 pm

    My son had the most horrible reaction last night to the Equate Children’s allergy! I want to know who I need to contact. He was hallucinating, sleep walking, with pupils the size of saucers. I had to make sure he was breathing. Basically passed out for 15 hours. He has NEVER reacted to anything in 10 years.

    Reply

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