Orajel Baby — Class I drug recall D-0506-2025
Ongoing recall by Church & Dwight Inc, reported 2025-07-09, distributed nationwide. Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
| Recall number | D-0506-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Church & Dwight Inc, Princeton, NJ, United States |
| Recall initiated | 2025-06-06 |
| Classified | 2025-07-03 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 695,880 cartons |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 00310310400002 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0506-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.