Summary
- Company Announcement Date:
- June 06, 2025
- FDA Publish Date:
- June 06, 2025
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Microbial contamination
- Company Name:
- Church & Dwight Co., Inc.
- Brand Name:
-
Brand Name(s)
Zicam® and Orajel™
- Product Description:
-
Product Description
Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs
Company Announcement
Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. The products are being recalled 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. To date, no serious adverse events associated with the affected product have been reported.
The recalled products were distributed nationwide in the United States and in Puerto Rico.
Recalled Product Information
- Zicam® Cold Remedy Nasal Swabs, with UPC 732216301205, all lots: A zinc-free, homeopathic cold remedy swab designed to shorten the duration of the common cold.
- Zicam® Nasal AllClear Swabs, with UPC 732216301656, all lots: A nasal cleansing swab product (discontinued in December 2024).
- Orajel™ Baby Teething Swabs, with UPC 310310400002, all lots: Pre-moistened swabs designed to soothe teething discomfort in infants and toddlers.
What Consumers Should Do
Consumers who have purchased any of the recalled products should stop using the product immediately. Please visit www.churchdwightrecall.com or call its Consumer Relations team at (800) 981-4710 for a full refund. Any additional questions can also be directed to its Consumer Relations team Monday through Friday, 9am – 5pm ET.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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.
About Church & Dwight Co., Inc.
Church & Dwight Co., Inc. is a leading manufacturer of consumer household and personal care products. For more information, visit www.churchdwight.com.
Media Contact:
Keith Walsh
keith.walsh@edelman.com
Company Contact Information
- Consumers:
- Consumer Relations Team
- (800) 981-4710
Product Photos
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