Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (… recall
FDA recall D-0506-2025 · initiated Jun 6, 2025
Church & Dwight Inc recalled Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.… in Jun 2025 — an FDA Class I recall (D-0506-2025) because Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 695,880 cartons
Details
- 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.
- Recalling company
- Church & Dwight Inc
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Jun 6, 2025
- FDA report date
- Jul 9, 2025
Frequently asked
- Was Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.… recalled?
- Church & Dwight Inc recalled Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.… in Jun 2025 — an FDA Class I recall (D-0506-2025) because Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.… recalled?
- Per the FDA enforcement record, the reason for recall D-0506-2025 was: Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
- Is a recalled Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.… are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — All Lots.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0506-2025.