FDA Recall D-0506-2025

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

Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.

Lot / code: All Lots.

Quantity: 695,880 cartons

Reason for recall

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

Recall record

Recall number: D-0506-2025
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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