D-0506-2025 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 9, 2025
- Initiation Date
- June 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 695,880 cartons
Product Description
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 Pattern
Nationwide in the USA.
Code Information
All Lots.