Children’s Advil Recall: What Parents Need to Know About the 2018 Suspension Packaging Alert

Understanding packaging swaps and dosing pitfalls to ensure safe ibuprofen use in kids.

By Medha deb

Created on Sep 22, 2025

Understanding packaging swaps and dosing pitfalls to ensure safe ibuprofen use in kids.

Children’s Advil Recall: Understanding the 2018 Bubble Gum Liquid Suspension Alert

In August 2018, parents, caregivers, and healthcare professionals across the United States received concerning news: Pfizer, Inc. issued a voluntary nationwide recall for one lot of Children’s Advil Suspension Bubble Gum Flavored Liquid (4 fluid ounces). This recall, prompted by a packaging inconsistency, highlighted important lessons about medicine dosing safety and consumer vigilance. This article covers the essential details of the recall, its implications, and expert recommendations for families and providers.

Background: The Children’s Advil Recall Explained
The Packaging Error: What Went Wrong?
Potential Risks: Ibuprofen Overdose in Children
Lot Information: What Product Was Recalled?
Immediate Actions for Parents and Caregivers
How to Report Adverse Events or Quality Issues
Responses and Recommendations from Pfizer
Best Practices for Safe Medicine Dosing
Frequently Asked Questions (FAQs)

For parents concerned about the safety of over-the-counter medications for young children, it's crucial to stay informed. Discover more about recent issues surrounding infant ibuprofen and ensure your family's safety by reading our comprehensive guide on the Infant Ibuprofen Recall. This article provides valuable insights and preventative measures to protect your child from potential risks.

Background: The Children’s Advil Recall Explained

On August 27, 2018, Pfizer Consumer Healthcare announced a voluntary recall of a specific lot of Children’s Advil Suspension Bubble Gum Flavored Liquid in the 4-ounce bottle size. This action followed reports from parents and healthcare providers that the product’s packaging could cause dosing confusion and potential medication errors. The recall was conducted in coordination with the U.S. Food and Drug Administration (FDA).

Understanding the full scope of medication recalls is vital for every parent. To further safeguard your child’s health, be sure to review our detailed overview of the Nationwide Children's Cough Syrup Recall. This resource explains the associated risks and provides actionable steps for ensuring the medicine you use at home is safe.

The Packaging Error: What Went Wrong?

The core issue prompting the recall was a mismatch between the medicine’s dosing cup and the dosing instructions on the bottle label. Specifically:

The dosage cup included with the product was marked with measurements in teaspoons (tsp).
The dosing instructions printed on the bottle label were written in milliliters (mL).

This discrepancy introduced a risk that caregivers might inadvertently administer an incorrect dose if they confused teaspoons and milliliters. Given that 1 teaspoon equals approximately 5 milliliters, this could mean a child would receive too much or too little ibuprofen.

Potential Risks: Ibuprofen Overdose in Children

When it comes to children's health, every detail counts. If you're curious about similar medication safety issues, explore our in-depth consumer guide on Bayer’s Alka-Seltzer Plus Recall. This guide not only outlines potential risks but also emphasizes preventive strategies that can help parents safely navigate medication use.

Ibuprofen is a common non-steroidal anti-inflammatory drug (NSAID) used to relieve fever and minor aches and pains in children. However, like all medications, correct dosing is crucial—especially with children, where dosing errors can have more significant impacts.

Potential symptoms of ibuprofen overdose include:

Nausea
Vomiting
Headache
Drowsiness
Blurred vision
Dizziness

More severe adverse events can occur at higher doses, making precise measurement and administration critical. The FDA recommended that any child experiencing these symptoms after using the recalled product should receive prompt medical attention.

Lot Information: What Product Was Recalled?

The recall was limited to a single lot of the product, which was distributed to wholesalers, distributors, and retailers nationwide from May to June 2018. Below are the full details:

In light of recent recalls, it's essential for parents to stay vigilant about baby formula safety. Arm yourself with knowledge by referring to our critical article on the Nutramigen Baby Formula Recall. This resource breaks down the important details you need to ensure your baby's nutrition is safe and reliable.

Product	NDC	Lot Number	Expiration Date	Configuration
Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle	0573-0207-30	R51129	11/20	4 FL OZ (120 mL) Bottle

No other flavors or lots of Children’s Advil, or Advil products intended for other age groups, were part of this recall.

Immediate Actions for Parents and Caregivers

If you have purchased this product, here’s what you should do immediately:

Check your medicine cabinet for Children’s Advil Bubble Gum Flavored Suspension with the above lot number (R51129).
If you find a matching bottle, stop using it right away.
Do not administer this medicine to any child.
Quarantine the product to prevent accidental use by anyone in your household.
Follow recall return instructions or contact the Pfizer Consumer Healthcare Information Line (1-800-882-3845) for guidance.
If your child has already taken the product and you have concerns about possible overdose, contact your pediatrician or healthcare provider immediately.

If you're concerned about medication safety, there are numerous recalls impacting various products. Stay informed about other critical situations by checking out our exclusive coverage on the recent GlaxoSmithKline Asthma Inhaler Recall. This article outlines the risks involved and how to take action if you are affected.

How to Report Adverse Events or Quality Issues

Both Pfizer and the FDA urge consumers and professionals to report any adverse reactions or quality concerns involving this product. Here’s how:

To Pfizer: Call the Consumer Healthcare Information Line at 1-800-88-Advil (1-800-882-3845) between 9 a.m. and 5 p.m. EST, Monday through Friday.
To the FDA (MedWatch Adverse Event Reporting Program):
- Submit a report online.
- Request a reporting form by calling 1-800-332-1088; complete and mail or fax (1-800-FDA-0178).

Responses and Recommendations from Pfizer

Pfizer’s statement emphasized their commitment to safety and outlined steps taken in response to the error:

Notifying wholesalers, distributors, and retailers about the recall.
Instructing all parties in the supply chain to quarantine remaining inventory from the affected lot.
Arranging for the safe return and disposal of recalled bottles.
Encouraging downstream partners to notify any accounts or locations that may have received the recalled inventory.
Clarifying that the recall was conducted in full collaboration with the U.S. FDA and under its knowledge.

Pfizer reiterated that patient safety is paramount at every step, from production through distribution.

Best Practices for Safe Medicine Dosing

This recall served as a vital reminder for families and caregivers about best practices when administering medications to children:

Always read and follow dosing instructions on the label with care.
Use the correct measuring device provided with the medicine. If measurements on the cup and bottle instructions do not match (e.g., teaspoons vs. milliliters), do not assume equivalence.
Know how to convert between teaspoons and milliliters if absolutely necessary: 1 teaspoon (tsp) = 5 milliliters (mL).
Never use household spoons as they are unreliable for measuring medication doses.
If there is ever confusion about how much medicine to give, consult a pharmacist or healthcare provider before administering the medicine.
Store medicines out of reach of children and check expiration dates regularly.

Frequently Asked Questions (FAQs)

Q: Why was only one lot of Children’s Advil recalled?

A: The recall was strictly limited to lot number R51129 of Children’s Advil Bubble Gum Flavored Suspension 4 FL OZ because the packaging error was specific to this lot. No other lots or flavors were affected.

Q: What should I do if my child already received a dose from the recalled product?

A: Monitor your child for any symptoms like nausea, vomiting, dizziness, blurred vision or drowsiness. If you notice any of these, or if you are uncertain about the dose your child received, contact your pediatrician or healthcare provider promptly.

Q: How can I tell if my product is part of the recall?

A: Check the bottle for the lot number R51129, NDC 0573-0207-30, and expiration date 11/20. Only 4 FL OZ bottles of Bubble Gum Flavored Suspension are affected.

Q: Will there be a refund or exchange for recalled products?

A: Pfizer coordinated product returns through its partners and the recall hotline. Contact them directly or your retailer for assistance with a return or refund, and do not use the medicine.

Q: How common are medication recalls like this?

A: Medication recalls are relatively uncommon but do occur periodically when issues related to safety, labeling, or packaging arise. The FDA maintains a searchable list of recalls for public awareness, and manufacturers are required to notify the public and healthcare providers immediately when safety concerns are identified.

Q: Where can I find more information or updates about medicine recalls?

A: Visit the FDA’s Drug Recalls page or contact the Pfizer Consumer Healthcare Information Line (1-800-882-3845) for the latest information on specific products.

Conclusion

This incident stressed the critical importance of vigilance and clarity in pediatric medicine dosing. Even a minor packaging or labeling inconsistency can have serious effects, especially for very young patients. Parents and caregivers should always check both medicine labels and dosing tools before administration and should not hesitate to consult a healthcare professional with any concerns. By staying informed and attentive, families can help prevent dosing errors and ensure safer treatment for their children.

References

Author

medha deb

Medha Deb is an editor with a master's degree in Applied Linguistics from the University of Hyderabad. She believes that her qualification has helped her develop a deep understanding of language and its application in various contexts.

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