FDA MedWatch - Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs by Church & Dwight Co.

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TOPIC: Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs by Church & Dwight Co.: Recall - Due to Microbial Contamination

AUDIENCE: Consumer, Health Care Professional, Pediatric

ISSUE: Church & Dwight Co. is recalling all lots within expiry of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs due to potential microbial contamination identified as fungi in cotton swab components. Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries. The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions. 

The recalled products were distributed nationwide in the United States and in Puerto Rico.

This recall is limited exclusively to Zicam and Orajel swab products. All other Zicam and Orajel products, including Zicam RapidMelts, are not affected by this recall. 

To date, no serious adverse events associated with the affected product have been reported. 

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 

Recalled Product Information

• Zicam Cold Remedy Nasal Swabs, all lots: A zinc-free, homeopathic cold remedy swab designed to shorten the duration of the common cold.

• Zicam Nasal AllClear Swabs, all lots: A nasal cleansing swab product (discontinued in December 2024).

• Orajel Baby Teething Swabs, all lots: Pre-moistened swabs designed to soothe teething discomfort in infants and toddlers.

RECOMMENDATIONS: 

• Consumers who have purchased any of the recalled products should stop using the product immediately.

• Please visit www.churchdwightrecall.com or call the Consumer Relations team at (800) 981-4710 for a full refund. Any additional questions can also be directed to the Consumer Relations team.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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