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McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing problems. The company initiated a recall of certain oral suspension products distributed between March 2008 and June 2008 due to the potential of bacteria in raw materials used to manufacture the finished product. There are no illnesses reported by patients using this product. The full list of recalled product lots can be accessed on the company's website.
All products manufactured met internal specifications. However, the company is implementing this recall because during this period, an unused portion of one inactive ingredient did not meet all quality standards. Therefore, as a precautionary measure, it was decided to recall all Children's and Infants' TYLENOLŪ liquid products listed below, which were made during this time.
Parents and caregivers who have questions or concerns should contact their child's health care provider or the Tylenol consumer call center at 1-800-962-5357 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time). Consumers can find the lot numbers on the bottom of the box containing the liquid product and also on the sticker that surrounds the product bottle. The lot numbers of the affected products are listed below.
These actions do not apply to Children's TYLENOLŪ Meltaways and Junior Strength TYLENOLŪ Meltaways. The voluntary recall applies only to select lots of Children's and Infants' TYLENOLŪ liquid products.
Recalled Products - Full List
Lot #
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Product Description
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SBM041, SBM067, SCM037, SDM027, SEM109
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Children's Tylenol Plus Cold MS Suspension
4 oz. Grape
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SBM042, SCM015, SCM036, SDM034
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Children's Tylenol Suspension
4oz. Grape
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SBM043, SBM044, SCM029
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Children's Tylenol Suspension
4oz. Bubble Gum
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SBM045, SCM011, SCM030, SDM035
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Children's Tylenol Suspension
4oz. Strawberry
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SBM064, SCM033, SDM020
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Infant's Tylenol Suspension Drops
1/4oz. Grape
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SBM065, SCM005, SCM006, SDM032
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Infant's Tylenol Suspension
1/2oz. Cherry
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SBM066, SCM068
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Children's Dye Free Suspension
4oz. Cherry
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SBM068, SCM035, SCM070, SCM080, SDM005
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Children's Tylenol Suspension
4oz. Cherry
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SBM069, SBM070, SCM081, SDM006
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Children's Tylenol Plus Cough & Runny Nose
4oz. Cherry
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SCM012, SCM067, SDM007, SDM068
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Infant's Tylenol Suspension Drops
1/2oz. Grape*
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SCM013, SCM014, SCM069
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Children's Tylenol Plus Flu
4oz. Bubble Gum
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SCM016, SFM024
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Children's Tylenol Plus Cold Suspension
4oz. Grape
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SCM017
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Children's Tylenol Plus Cough/ST Suspension
4oz. Cherry
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SCM082, SDM039, SDM040
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Infant's Tylenol Suspension Drops
1oz. Grape
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SCM083, SCM084, SDM008
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Infant's Tylenol Dye Free Suspension
1oz. Cherry
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SDM064
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Children's Tylenol Pediatric Suspension
1oz. Cherry
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SDM038, SDM009
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Infant's Tylenol Suspension Drops
1oz. Cherry
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SDM033
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Children's Tylenol Plus Cold/Allergy
4oz. Bubble Gum
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SDM078
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Infant's Tylenol Drops
1oz. Grape
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SCM034
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Infant's Tylenol Suspension Drops H/G
1/2oz. Grape
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SDM028
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Children's Tylenol Suspension
4oz. Cherry, Hospital Govt.
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*This product may be contained in certain JOHNSON'SŪ Baby Relief Kits. Please check the lot number on the Tylenol bottle in your kit to determine if it is included in this recall
Used with permission from the U.S. Department of Health and Human Services. For more information on the Children's and Infants' TYLENOLŪ Recall, click here.
The information provided in this article by the United States Centers for Disease Control and Prevention is news that iMOM thinks you need to know. Recommendations are the opinion of the CDC and not necessarily those of iMOM.
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