Nationwide Recall of Certain Tylenol Products

McNeil Consumer Healthcare is recalling certain lots of oral suspension children's and infants' Tylenol products.
The company is recalling certain oral suspension products distributed between March 2008 and May 2008 because bacteria may have been present in raw materials used to make the finished product. The company's analysis of the finished product did not reveal any bacterial contamination.

These products are subject to the recall:

• Children's Tylenol Plus Cold MS suspension (4 oz.) grape flavor
• • UPC: 300450391049
  • Code number: 3910400
  • Lot numbers: SBM041, SBM067, SCM037, SDM027, SEM109
• Children's Tylenol suspension (4 oz.) grape flavor
• • UPC: 300450296047
  • Code number: 2960400
  • Lot numbers: SBM042, SCM015, SCM036, SDM034
• Children's Tylenol suspension (4 oz.) strawberry flavor
• • UPC: 300450493040
  • Code number: 4930400
  • Lot numbers: SBM045, SCM011, SCM030, SDM035
• Infants' Tylenol suspension drops (0.25 oz.) grape flavor
• • UPC: 300450122407
  • Code number: 1224000
  • Lot numbers: SBM064, SCM033, SDM020
• Infants' Tylenol suspension (0.5 oz) cherry flavor
• • UPC: 300450186157
  • Code number: 1861500
  • Lot numbers: SBM065, SCM005, SCM006, SDM032
• Children's Tylenol dye-free suspension (4 oz.) cherry flavor
• • UPC: 300450166043
  • Code number: 1660400
  • Lot numbers: SBM066, SCM068
• Children's Tylenol suspension (4 oz.) cherry flavor
• • UPC: 300450123046
  • Code number: 1230400
  • Lot numbers: SBM068, SCM035, SCM070, SCM080, SDM005
• Children's Tylenol Plus Cough & Runny Nose (4 oz.) cherry flavor
• • UPC: 300450249043
  • Code number: 2490400
  • Lot numbers: SBM069, SBM070, SCM081, SDM006
• Infants' Tylenol suspension drops (0.5 oz.) grape flavor
• • UPC: 300450122155
  • Code number: 1221500
  • Lot numbers: SCM012, SCM067, SDM007, SDM068
• Children's Tylenol Plus Flu (4 oz.) bubble gum flavor
• • UPC: 300450386045
  • Code number: 3860400
  • Lot numbers: SCM013, SCM014, SCM069
• Children's Tylenol Plus Cold suspension (4 oz.) grape flavor
• • UPC: 300450387042
  • Code number: 3870400
  • Lot numbers: SCM016, SFM024
• Children's Tylenol Plus Cough/ST suspension (4 oz.) cherry flavor
• • UPC: 300450247049
  • Code number: 2470400
  • Lot number: SCM017
• Infants' Tylenol suspension drops (1 oz.) grape flavor
• • UPC: 300450122018
  • Code number: 1220100
  • Lot numbers: SCM082, SDM039, SDM040
• Infants' Tylenol dye-free suspension (1 oz.) cherry flavor
• • UPC: 300450167019
  • Code number: 1670100
  • Lot numbers: SCM083, SCM084, SDM008
• Children's Tylenol pediatric suspension (1 oz.) cherry flavor
• • UPC: 300450123015
  • Code number: 1230100
  • Lot number: SDM064
• Infants' Tylenol suspension drops (1 oz.) cherry flavor
• • UPC: 300450186300
  • Code number: 1863000
  • Lot numbers: SDM038, SDM009
• Children's Tylenol Plus Cold/Allergy (4 oz.) bubble gum flavor
• • UPC: 300450390042
  • Code number: 3900400
  • Lot number: SDM033
• Infants' Tylenol drops (1 oz.) grape flavor
• • UPC: 300450122100
  • Code number: 1221000
  • Lot number: SDM078
• Infants' Tylenol suspension drops for hospital/government (0.5 oz.) grape flavor
• • UPC: 350580144183
  • Code number: 1221800
  • Lot number: SCM034
• Children's Tylenol suspension for hospital/government (4 oz.) cherry flavor
• • UPC: 350580123034
  • Code number: 1230300
  • Lot number: SDM028

Parents and caregivers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. If consumers determine they have one or more of the recalled products, they can contact McNeil Consumer Healthcare's Customer Care Center at 800-962-5357 to receive a coupon for a new bottle.

Consumers and health care providers with questions can call the company's Medical Affairs Department at 800-962-5357 Monday through Friday from 8 a.m. to 8 p.m. EDT.

The FDA is working closely with the company to monitor this recall. There are no illnesses reported by patients using this product.

Adverse events and product quality problems can be reported to the FDA's MedWatch Adverse Event Reporting program:

• Online: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• By phone: 800-FDA-1088
• By postal mail: Return postage-paid FDA form 3500 to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• By fax: 800-FDA-0178