Why it was recalled
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
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.
Lot numbers, UPCs & expiration codes
All Lots.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0506-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jun 6, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 695,880 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Church & Dwight Inc
Original FDA data
Every field from FDA enforcement report D-0506-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97031
- Address
- 469 N Harrison St
- Code information
- All Lots.
- Postal code
- 08540-3510
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0506-2025
- Classification
- Class I
- Recalling firm
- Church & Dwight Inc
- Product quantity
- 695,880 cartons
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jun 6, 2025
- Initial firm notification
- Press Release
- Center classification date
- Jul 3, 2025