FDA recall record · openFDA

Church & Dwight Inc

5 FDA recalls on record (2023–2025) — 4 drug,1 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. 2

Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. 1

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis 1

Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a p 1

Recalls

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 S Class I 2025-06-06 ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing Class I 2025-06-06 ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 Class I 2025-06-06 TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Class I 2023-09-08 Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test r Class II 2023-01-25

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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