Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free
Summary
The FDA issued a Class II for Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 by Church & Dwight Co., Inc.. Reason: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing.
Details
Source
Drug Recall
External ID
D-0790-2026
Action Date
2026-09-02
Status
Ongoing
Category
drug
Product Description
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
Lot/Code Info: Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.
Quantity Affected: 318,600 cartons
Reason for Recall
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-10
Company
Ewing, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Church & Dwight Co., Inc. has 6 FDA actions in our database, including 2 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Church & Dwight Co., Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Church & Dwight Co., Inc. have FDA actions?
Church & Dwight Co., Inc. has 6 FDA actions in our database, including 2 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0790-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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