Recall of Babies’ and Children’s Tylenol, Motrin, Zyrtec and Benadryl

The U.S. Food and Drug Administration (FDA) and McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products that were manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

The press release states that the recall is because “some of these products may not meet required quality standards” and that it is “not being undertaken on the basis of adverse medical events”.

Apparently, some of the products listed below 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. Although the risk from these products is perceived to be small, you are advised to stop using them if you have them.

If you have any questions or concerns, you can contact the company at 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). If you notice any adverse reactions to these products, you can report them to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Note: You can find the product NDC numbers on the label of the bottle, above the brand name

PRODUCTS AND THEIR NDC NUMBERS

TYLENOL® INFANTS’ DROPS

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR
50580-144-01

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR*
50580-144-15

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE
50580-167-01

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR
50580-143-15

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR
50580-143-30

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE – HOSPITAL
50580-144-18

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE – SAMPLE
50580-144-40

CHILDREN’S TYLENOL® SUSPENSIONS

CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR
50580-123-02

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR
50580-123-04

CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR
50580-166-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH
50580-296-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
50580-407-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR
50580-493-04

CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE
50580-123-01

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL
50580-123-03

CHILDREN’S TYLENOL® PLUS SUSPENSIONS

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR
50580-247-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR
50580-249-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR
50580-253-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR
50580-254-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR
50580-255-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR
50580-386-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR
50580-387-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR
50580-390-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR
50580-391-04

MOTRIN® INFANTS’ DROPS
CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE
50580-198-01

CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE
50580-198-15

CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR*
50580-100-15

CHILDREN’S MOTRIN® SUSPENSIONS

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE
50580-184-04

CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR
50580-601-02

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR
50580-601-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR
50580-215-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR
50580-603-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR
50580-604-04

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE
50580-603-01

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE
50580-604-01

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE
50580-601-01

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL
50580-601-50

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR
50580-902-04

CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES

CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP
50580-721-04

CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP
50580-730-04

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE
50580-730-15

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM
50580-721-15

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID
50580-721-08

CHILDREN’S BENADRYL® ALLERGY LIQUIDS IN BOTTLES

CHILDREN’S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID
50580-535-04

*CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR is also included in JOHNSON’S ® Baby Relief Kit.

*CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON’S ® Baby Relief Kit.