FDA Recall D-0504-2025

Church & Dwight Inc · Princeton, NJ

Class I — life-threatening Ongoing 342 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5

Lot / code: All lots.

Quantity: 3,374,918 cartons

Reason for recall

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

Recall record

Recall number: D-0504-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA.
Recall initiated: 2025-06-06
Classified by FDA Center: 2025-07-03
FDA published: 2025-07-09
Recalling firm: Church & Dwight Inc
Firm location: Princeton, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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