FDA Drug recall D-0506-2025
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, Ma…
- FDA Drug
- Class I
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class I recall of 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, Ma… by Church And Dwight, citing microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0506-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-06-06 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Church And Dwight |
| Distribution | US |
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
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Identifiers
| upc | 310310400002 |
|---|---|
| code_info | All Lots. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0506-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.