FDA Closes Recall of Zicam Nasal Swabs Over Microbiological Testing Deviations
The FDA has closed the Class II recall of certain Zicam Cold Remedy Medicated Nasal Swabs, citing CGMP deviations and out-of-limit microbiological test results.
2 reports on this incident · first at Sep 7, 2026, 7:52 p.m. ET
Earlier reports
Sep 7, 2026, 7:52 p.m. ETFirst report
Zicam Nasal Swabs Recalled Over Microbiological Testing Deviations
The FDA has classified as Class II a recall initiated by Church & Dwight Co., Inc. on August 10, 2026, for Zicam Cold Remedy Medicated Nasal Swabs. The recall, listed as ongoing in the FDA's enforcement report dated September 2, 2026, covers 318,600 cartons distributed nationwide. The reason cited is CGMP deviations; an FDA inspection of the contract manufacturer noted out-of-limit results for microbiological testing.
The affected product is described as 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. Affected lots are UN52882 (exp. 04/30/2028), UN53431 (exp. 06/30/2028), and UN60411 (exp. 08/31/2028), with UPC 732216301205.
According to the FDA's recall classification definitions, Class II is used when a product may cause temporary or medically reversible harm and where the probability of serious adverse health consequences is remote. The recall number is D-0790-2026.
Church & Dwight has had five other FDA recall actions since 2021, all Class II, involving potential metallic mesh material in certain vitafusion products. These prior actions are unrelated to this recall and do not indicate a cause for the current action.
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Revision history
- Version 17 Sept 2026, 23:52current
First published.
- Version 17 Sept 2026, 23:54current
First published.
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