If you or a loved one experienced serious or life-threatening blood infections after using Zicam® Cold Remedy Nasal Swabs or related swab products, you may be entitled to pursue compensation through a product liability or contaminated medical product lawsuit.
At Schmidt & Clark, LLP, we are dedicated to helping individuals harmed by contaminated medical devices and home remedies. Our experienced legal team is here to guide you through the process and fight for the recovery you deserve.
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Table Of Contents
- Zicam (Microbial Contamination) Recall Lawsuit Overview
- Latest Zicam Lawsuit Updates
- Zicam Lawsuit Statistics
- FDA Reports and Statistics
- Zicam Swab Injuries & Side Effects
- Do You Qualify for a Zicam Lawsuit?
- Zicam Recall Information
- Statute of Limitations for Zicam Lawsuits
- Frequently Asked Questions
- References
Zicam (Microbial Contamination) Recall Lawsuit Overview
The Zicam lawsuit concerns allegations that the Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs were contaminated with fungi on the swab tips, posing a risk of serious or life-threatening bloodstream infections in vulnerable users.
The FDA classified the recall as Class III—indicating risk of serious harm due to microbial contamination—on June 6, 2025.
Over-the-counter swabs distributed nationwide, including Puerto Rico, were immediately pulled from retail shelves.
To date, no confirmed adverse events have been reported; however, the contamination risk is especially high for children, seniors, and those with compromised immune systems or nasal injuries.
Latest Zicam Lawsuit Updates
- June 11, 2025 – CBS News and ABC11 report widespread recall and life-threatening contamination risk noted on patient alerts.
- June 9, 2025 – FDA issues MedWatch Safety Alert to health professionals advising immediate patient guidance and discontinuation of use.
- June 6, 2025 – Church & Dwight voluntarily recalls all product lots nearing expiry nationwide due to fungal contamination risk.
- June 2020 – FDA previously warned about intranasal Zicam gel causing anosmia; subsequent litigation led to a $12 million settlement.
Zicam Lawsuit Statistics
- Products recalled: Zicam Cold Remedy Nasal Swabs (UPC 732216301205), Zicam Nasal AllClear Swabs (UPC 732216301656), Orajel Baby Teething Swabs (UPC 310310400002).
- Recall scope: All lots still within expiry sold nationally in the U.S. and Puerto Rico.
- Adverse reports: No reported infections yet—but risk remains substantiated.
- Prior litigation: Zicam faced lawsuits culminating in a $12 million settlement over anosmia in 2009.
- Market reach: Zicam brands are sold at national retailers including CVS, Walmart, Kroger, and Rite Aid.
FDA Reports and Statistics
The FDA’s recall classification identifies fungal contamination on the cotton tips of swabs, which can cause bloodstream infections when introduced to compromised mucosal tissue.
Swabs sold OTC may bypass sterile manufacturing standards, heightening contamination risk. Although no adverse events have been confirmed, similar recalls numbered nearly 300 in the past two years, with hundreds hospitalized and dozens of deaths.
Zicam Swab Injuries & Side Effects
Potential adverse outcomes include:
- Systemic infection (fungemia): Fungal blood infections potentially requiring IV antifungal therapy.
- Sepsis: Life-threatening systemic response to infection if left untreated.
- Pediatric risk: Infants using teething swabs may be at especially high risk due to immature immune systems.
Do You Qualify for a Zicam Lawsuit?
- You used Zicam Cold Remedy Nasal Swabs, Nasal AllClear Swabs, or Orajel Baby Teething Swabs prior to June 6, 2025.
- You experienced symptoms such as fever, chills, malaise, or systemic infection after use.
- A healthcare provider tested or treated you for possible fungal or bacterial bloodstream infection.
- You retained any proof of purchase, lot number or the product itself.
- You can provide a medical timeline linking swab use and subsequent illness.
Evidence Required for a Zicam Lawsuit
- Medical records: ER/hospital notes, lab tests indicating fungemia or sepsis.
- Product proof: Photographs of swab packaging and lot/distribution information.
- Purchase documentation: Receipts, photos at point-of-sale.
- Recall documentation: Confirmation from Church & Dwight or FDA recall notices.
- Expert testimony: Infectious disease expert linking condition to device contamination.
Damages You Can Recover
- Medical expenses: Hospitalization, ICU, IV medications, follow-up care.
- Lost wages: Income lost during treatment and recovery.
- Pain & suffering: Compensation for physical and emotional trauma.
- Punitive damages: Could be awarded if misconduct or negligence is proven.
Previous medical device contamination suits have resulted in $100,000–$500,000+ settlements depending on injury severity [similar litigation].
Zicam Recall Information
- Recall date: June 6, 2025 by Church & Dwight, in coordination with FDA.
- Products recalled: Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, Orajel Baby Teething Swabs—all lots within expiry.
- Reason: Fungal contamination of cotton swabs posing infection risk.
- Remedy: Discontinue use; return for full refund via Church & Dwight Recall site or hotline (800‑981‑4710).
- Sterility advisory: Products not sterile; unsuitable for mucosal application.
Statute of Limitations for Zicam Lawsuits
Product liability claims typically must be filed within **1–3 years** depending on state laws (e.g., New York: 1 year, California: 3 years). Prompt action is essential to preserve medical documentation and product evidence. The countdown starts when illness is diagnosed.
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Frequently Asked Questions
- How do I start a claim? Contact Schmidt&Clark—our team will review medical records, confirm eligible use, and file your lawsuit.
- Do I need confirmation of fungal infection? A clinical diagnosis or lab result strengthens your case, but documented treatment for sepsis after swab use may suffice.
- Can I file without illness? No—legal claims require documented harm or treatment resulting from product use.
- Are children eligible? Yes—use of Orajel Teething Swabs by infants or toddlers may result in eligibility if illness occurred.
- Will filing a lawsuit affect my refund? No—returning the product for refund does not waive your legal rights.
- How long will the case take? Settlements typically resolve in 12–24 months; serious injury cases may take longer.
- Could punitive damages apply? Yes—if it is shown the company ignored safety standards or concealed contamination.
- Is Zicam safe now? Only unaffected products remain on shelves; check recall lists carefully.
References
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/church-dwight-co-inc-issues-voluntary-nationwide-recall-zicamr-cold-remedy-nasal-swabs-zicamr-nasal