US Drug Recall Register
Class I · High risk Ongoing Initiated Jun 6, 2025 (15 months ago)

Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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

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.

Recalling firm
Church & Dwight Inc
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0506-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.