Attorney at Graves McLain Injury Lawyers

Practice Areas: Wrongful Death, Medical Malpractice, Bad Faith Insurance, Car Accidents, T-Bone Tractor-Trailer Accidents, Dangerous Drugs

Medicines meant to help children feel better should never cause harm. But sometimes, contamination or poor manufacturing practices can put families at risk. Over the years, several over-the-counter (OTC) children’s medicines have been recalled because of safety issues, such as microbial contamination.

One major case involved a North Carolina-based company called King Bio, which issued a nationwide recall for multiple children’s homeopathic products after the FDA found potential contamination. While this happened a few years ago, it remains a critical reminder for parents today. Defective drug recalls still occur, and understanding your legal rights in Oklahoma is an essential step if your family is affected.

Let’s explore what happened, what the risks are, and what to do if your child was exposed to a recalled medication.

Overview of Children’s Medicine Recalls

Back in August 2018, King Bio voluntarily recalled 32 homeopathic medicines designed for infants and children.

These included popular items like:

  • Chicken Pox Symptom Relief
  • Children’s Appetite Enhance
  • DK Newborn Tonic
  • DK Colic Relief
  • Kids Bed Wetting (NP)

These products were found to be contaminated with potentially harmful bacteria during a routine FDA inspection.

This wasn’t the first major recall involving children’s medicine. In 2010, McNeil Consumer Healthcare, a division of Johnson & Johnson, pulled over 40 medications off the shelves—including children’s Tylenol, Motrin, and Benadryl—due to contamination risks, improper ingredient levels, and the presence of foreign materials like metal particles.

These events highlight why it’s so crucial for parents to stay alert to FDA recall announcements. Even seemingly harmless medicine can become dangerous if it’s been poorly manufactured.

FDA Findings and Regulatory Background

The FDA plays a key role in monitoring the safety of medicines. In King Bio’s case, it found contamination with Burkholderia cepacia, a bacterium that can cause serious

infections—especially in children and those with weak immune systems. The company violated multiple manufacturing standards, resulting in a formal warning for failing to meet current good manufacturing practices under federal law.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention, and could result in infections that may be life‑threatening to certain individuals. – FDA Safety Alert.

In response to rising risks, the FDA introduced a targeted enforcement strategy in 2017 focused on high-risk homeopathic drugs, particularly those marketed to vulnerable populations.

Health Risks and Who’s at Risk

Even though no injuries were officially reported during the King Bio recall, the risk of harm was real. When children take medicines contaminated with bacteria, the outcomes might vary from minor pain to serious infections.

Infants, children, and those with weakened immune systems are at greater risk. The symptoms may include fever, rashes, digestive upset, or even respiratory problems, depending on the bacteria involved.

Parents should always take contamination warnings seriously—even if their child hasn’t shown any signs of illness. It’s better to be safe and consult a medical professional than risk an unseen infection getting worse.

Evidence and Legal Requirements in Oklahoma

If a recalled or defective drug harmed your child, you may have a legal case under Oklahoma product liability law. These cases are based on the idea that companies are responsible for making and selling safe products. If they fail to do so and someone gets hurt, they can be held accountable.

To support a legal claim, it’s essential to:

  • Keep the product and packaging (including lot number and expiration date)
  • Save any proof of purchase or receipts
  • Document your child’s symptoms and medical care
  • Consult an experienced product liability attorney

Oklahoma law allows families to pursue compensation for medical bills, pain and suffering, emotional distress, and other losses if a product was defective and caused harm.

What to Do After a Medication Recall

If you’ve discovered that a medicine in your home was recalled, here’s what to do:

  • Stop using the medicine immediately. Check the FDA’s website to confirm if the product is part of the recall, and keep the packaging and bottle. Even if no one has gotten sick, store the product safely in case it’s needed later as evidence.
  • If your child shows any symptoms or unusual reactions, visit a doctor and mention the recalled product. You can also report any problems directly to the FDA through their MedWatch reporting system.
  • Finally, consider speaking with a Tulsa-based attorney who handles product liability and defective drug cases. A lawyer can help you understand whether you have a valid claim and what your options are moving forward.

Legal Options in Tulsa and How Graves McLain Can Help

For families in Tulsa and across Oklahoma, defective drug injuries are covered under product liability law. These cases often involve complex medical and legal details. Graves McLain Injury Lawyers investigates thoroughly and works with experts to hold drug manufacturers accountable. We work on a contingency basis—no fees unless we recover compensation for you.

Summary of Major Children’s Medication Recalls

Date

Company

Number of Products

Reason for Recall

Health Risk Concern

April 2010McNeil (J&J)~40 OTC productsContaminants, ingredient issues, metal flecksPotential infection, incorrect dosage
Aug 2018King Bio32 productsMicrobial contamination, CGMP violationsSerious infections in vulnerable groups

FAQs

What should I do if I still have a recalled children’s medicine?

Please stop using the medicine, keep the packaging, report the product to the FDA, and store it safely in case it’s needed for a legal review.

Can I file a claim if no one got sick from the recalled medicine?

Possibly. If the product was defective and posed a risk, a lawyer can help you understand whether you still have a case based on exposure and emotional distress.

Why was King Bio’s recall so serious?

The products were contaminated with harmful bacteria and violated FDA manufacturing rules, making them unsafe—especially for children.

Does the FDA regulate homeopathic drugs?

Yes. While often marketed as natural remedies, homeopathic drugs are still considered drugs under federal law and must follow manufacturing standards.

How quickly do I need to act for a recall-related injury case in Oklahoma?

Oklahoma has a two-year limit to file most personal injury lawsuits. It’s best to speak with a lawyer as soon as possible.

What kind of compensation can families pursue?

You may be eligible for medical expenses, pain and suffering, lost wages, and other damages, depending on how the defective product affected your child.

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Conclusion

Even well-known or natural children’s medications can be unsafe when manufacturing standards aren’t followed. Recalls like King Bio’s serve as an important reminder that parents should always check for FDA warnings and act quickly if a product has been recalled.

If you believe your child was harmed by a contaminated or defective medication, preserving evidence and understanding your legal rights is crucial. Oklahoma product liability law allows families to pursue justice when a manufacturer’s failure puts children at risk.

Graves McLain Injury Lawyers in Tulsa helps families navigate these complex claims with care, experience, and no upfront cost. If you have questions or concerns about a recalled medicine, we’re here to help you take the next step.

When injury victims need a law firm with a reputation for excellence, turn to Graves McLain Injury Lawyers. We are a top-rated personal injury firm determined to be the best. With decades of award-winning representation, our clients recover the compensation they need to put their lives back together.

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