FDA Drugs recall ·
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0506-2025
- Date
- (initiated June 6, 2025)
- Company / brand
- Church & Dwight Inc
469 N Harrison St, Princeton, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 695,880 cartons
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots.
Distribution
Nationwide in the USA.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0506-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.