FDA recall D-0506-2025

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.

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-06-06

Report date

2025-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0506-2025