Orajel Baby recalled over sterility concerns

Recall date

June 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Church & Dwight Inc 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…

Recall number

D-0506-2025

FDA classification

Class I

Brand / firm

Church & Dwight Inc

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.