Infant Ibuprofen Recall: What Parents Need to Know About the Nationwide Safety Warning

Checking medication batches and dosage can prevent overdoses and boost child safety.

By Medha deb

Created on Sep 22, 2025

Checking medication batches and dosage can prevent overdoses and boost child safety.

When it comes to caring for infants with pain and fever, many parents rely on over-the-counter medications like ibuprofen. However, a recent nationwide recall of infant ibuprofen products in the U.S. has raised concerns among families and healthcare providers. This comprehensive guide covers the details of the recall, the specific risks for infants, affected products and batches, how to identify if your product is part of the recall, potential side effects, and guidance on what actions to take to ensure your child’s safety.

The Scope of the Infant Ibuprofen Recall

Which products are affected?

For more detailed information on related recalls affecting children’s medications, explore our comprehensive guide on the 2018 Children’s Advil recall, which outlines essential safety data and precautions for parents dealing with over-the-counter medications.

In late 2018 and early 2019, Tris Pharma Inc. announced a voluntary and expanded recall of their Infant’s Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL that was distributed nationwide in several leading retail stores, including Walmart, CVS, and Family Dollar. These products, commonly used as pain relievers and fever reducers for infants, were recalled due to potentially higher concentrations of ibuprofen in some bottles—reported to be up to 10% above the specified safe limit in certain batches.

Specific Lots and Retailers

The recall included multiple batches sold under store brands. Key details include:

Walmart (Equate): 50 mg per 1.25 mL in 0.5 oz bottles
CVS Health: 50 mg per 1.25 mL in 0.5 oz bottles
Family Dollar (Family Wellness): 50 mg per 1.25 mL in 0.5 oz bottles

To gain a broader understanding of the implications surrounding recalls in pediatric medications, check out our in-depth overview of the 2025 Nationwide Children’s Cough Syrup recall, where we discuss the risks, responses, and necessary precautions to take as a caregiver.

Lot numbers and expiration dates were explicitly listed in official recall notices. Here’s an illustrative table compiled based on public FDA and agency releases:

Lot Number	NDC	Expiration Date	Brand/Distributor
4718	59779-925-23	12/19	CVS Health
00717005A	49035-125-23	2/20	Walmart Equate
00717006A	55319-250-23	4/20	Family Dollar Wellness
00717009A	59779-925-23	6/20	CVS Health
00717015A	49035-125-23	8/20	Walmart Equate
00717024A	55319-250-23	9/20	Family Dollar Wellness

If you have ibuprofen purchased from these retailers, check the packaging for these lot numbers and expiration dates to determine if your bottle may be part of the recall.

Why Was the Infant Ibuprofen Recalled?

To further understand the challenges of ensuring safe feeding for your baby, explore our insights on the Nutramigen Baby Formula recall, which highlights critical information on product safety and what parents need to watch for.

The FDA and Tris Pharma determined that some bottles of the oral suspension could contain higher concentrations of ibuprofen than indicated on the label—up to 10% above the specified safe limit in those particular batches. The presence of higher concentrations was confirmed during quality checks and was considered a sufficient risk to warrant a nationwide recall. This step was taken as a precaution, even though safety issues linked to such small increases in dose are generally associated with much higher exposures (i.e., more than 700% the recommended dose). Nonetheless, a variance—even close to 10%—is considered a risk for infants who are especially vulnerable to medication dosing errors.

The FDA’s Role & Recall Process

The U.S. Food and Drug Administration (FDA) monitors drug safety and works with pharmaceutical companies on recalls and public health alerts.
Recalls can be voluntary (as in this case with Tris Pharma) or mandated by federal agencies if health risks are serious and actionable.
A recall aims to remove potentially defective or mislabeled medicine from circulation quickly, protecting consumers—especially the most vulnerable, such as infants.

If you are concerned about the safety of over-the-counter medications, learn about essential consumer protections with the Bayer Alka-Seltzer Plus recall, shedding light on what consumers should be aware of in similar circumstances.

Potential Health Effects and Risks for Infants

Why is this concerning?

Ibuprofen is generally safe for children and infants when given at recommended dosages. However, even relatively small increases in dose can place infants at risk due to their lower weight and developing organs. The risks associated with taking a higher-than-recommended dose of ibuprofen include:

Permanent NSAID-associated renal (kidney) injury, particularly for infants already susceptible due to underlying health issues
Nausea, vomiting, and epigastric pain
Diarrhea (less common)
Headache and tinnitus (ringing in the ears)
Gastrointestinal bleeding in severe cases

For more insights on the obligations of pharmaceutical companies to ensure safety, consider reading about the Tylenol Maker’s recent plea regarding metal contamination, providing a closer look at industry practices and consumer safety measures.

It is noteworthy that, according to Tris Pharma and the FDA, there were no reports of serious adverse side effects or hospitalizations at the time of the recall announcement.

What Should Caregivers and Healthcare Providers Do?

The FDA, Tris Pharma, and health authorities specifically advise:

Immediately stop administering any infant ibuprofen identified as being from an affected lot.
If you suspect your product is included in the recall, or if your child has experienced symptoms after taking ibuprofen, contact your physician or pediatrician for advice.
Do not return the product to the store (unless directed); contact the manufacturer or distributor for refund or replacement instructions.
Securely dispose of any affected medicine to prevent accidental use.

For additional context on how recalls can impact vitamin safety, take a look at our discussion on the Nature Made Vitamin recall, which highlights important health risks and consumer rights.

Consumers and healthcare professionals can direct questions regarding the recall to Tris Pharma’s Customer Service at 732-940-0358 for accurate support.

Understanding and Identifying Ibuprofen Overdose in Infants

Recognizing the early signs of ibuprofen overdose can be critical in avoiding further complications:

Nausea and vomiting
Stomach (epigastric) pain
Diarrhea (less common)
Tinnitus or ringing in the ears
Headaches or unexplained irritability
Signs of gastrointestinal bleeding (such as vomiting blood or black, tar-like stools)

If you observe any of these symptoms—especially in the context of a recently administered ibuprofen dose—seek medical advice immediately. Urgent symptoms such as excessive drowsiness, difficulty breathing, or signs of dehydration may require emergency medical attention.

How Did the Situation Occur?

According to Tris Pharma, the cause of the recall was determined during routine quality assessments. It was discovered that certain batches may have been manufactured with ibuprofen concentrations approximately 10% above the product label’s specification. The company initiated an internal investigation and undertook corrective actions to prevent recurrence. The voluntary recall was deemed necessary to protect public health, particularly since medication dosing accuracy is especially critical and difficult with infants.

How Often Do Such Recalls Happen?

Drug recalls for mislabeling or content deviations occur periodically in the pharmaceutical industry. Most are precautionary and do not result in confirmed harm, but the quick identification and removal of suspect batches are essential to protect vulnerable populations like infants. In this case, the recall highlights the importance of stringent manufacturing controls and regulatory oversight.

What Should You Do If You Have an Affected Product?

If you currently have a bottle of ibuprofen for infants and are concerned it may be part of the recall, follow these steps:

Check the lot number and expiration date on the bottle against official recall notices (see previous tables).
Contact Tris Pharma’s Customer Service with the lot number for verification.
Consult with your child’s healthcare provider for guidance—especially if your child has consumed any of the affected medicine.
For reimbursement or replacement, contact the retailer where you purchased the product, as many offer refund policies in the event of a safety recall.
Follow local guidelines for the safe disposal of medicines to avoid accidental ingestion.

Frequently Asked Questions (FAQs)

Should I throw away my bottle of infant ibuprofen?

If your product matches an affected lot, discontinue use immediately. You can consult your healthcare provider for confirmation. Securely dispose of the medicine or contact your retailer or Tris Pharma about refunds or exchanges.

Can I get a refund for recalled ibuprofen?

Yes, many retailers honor return and refund policies for recalled medicines. Contact the store where you purchased the ibuprofen or reach out directly to Tris Pharma Customer Service to discuss your options.

What symptoms should I watch for if my child has had the medicine?

Be vigilant for nausea, vomiting, stomach pain, headache, ringing in the ears, or gastrointestinal bleeding. In most cases, the risks from the affected batches are low, but call your pediatrician if you have concerns or your child develops symptoms.

Is ibuprofen still safe for infants?

Ibuprofen remains safe for infants when administered according to guidelines and when the product is not part of a recall. Always consult your pediatrician about appropriate medications and dosages for your child’s age and weight.

What was Tris Pharma’s response to the recall?

Tris Pharma, in partnership with the FDA, voluntarily expanded the recall, initiated a full internal review, and established public communication lines for concerned consumers. To date, no reports of severe harm from the affected products were received, and the recall was performed out of maximum precaution.

Key Takeaways for Parents and Caregivers

Always check medication labels carefully before each use, especially if you learn of a recent recall affecting products previously purchased.
Store medicines out of reach of children and follow up-to-date guidelines for the safe disposal of all pharmaceuticals.
In the event of any medicine-related recall, consult healthcare professionals before taking further action, and do not panic. The risk is low, especially if your child has not shown unusual symptoms.

Resources and Contact Information

Tris Pharma Customer Service: 732-940-0358
FDA Drug Safety: Visit the FDA’s official drug recall portal or contact your local health department for up-to-date information.
Report Potential Adverse Events: Notify your healthcare provider and report to FDA’s MedWatch program if your child experiences any adverse effects after taking medication from a recalled batch.

Additional Information: Understanding Drug Recalls

A drug recall is a proactive measure—a way to correct or remove defective medical products before widespread harm occurs. In most cases, especially for mild product specification issues such as this, the risk to consumers is low. However, prompt compliance and vigilance are crucial, especially for products intended for infants and young children.

Typical Recall Steps

Company discovers or is notified of a potential safety/quality issue.
A risk assessment is performed in coordination with federal agencies like the FDA.
Recall notices are issued, identifying affected products, lot numbers, and distribution chains.
Public notification through press releases, store postings, and healthcare provider outreach.
Instructions are provided for product return, refund, safe disposal, and reporting of adverse effects.
Internal corrective actions are implemented by the manufacturer to prevent repeat incidents.

As a parent or caregiver, staying informed about recent recalls and always checking batch information on medications before administration will help minimize risks to your children and loved ones.

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.

Read full bio of medha deb