Recalls / Class I
Class ID-0506-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Affected lot / code info
- All Lots.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Recalling firm
- Firm
- Church & Dwight Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 469 N Harrison St, Princeton, New Jersey 08540-3510
Distribution
- Quantity
- 695,880 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-06-06
- FDA classified
- 2025-07-03
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0506-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.