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Class I · Most seriousActive recall

Orajel Baby

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberAll Lots.
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forChurch & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2
Show the full FDA record
Full product labelOrajel 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 firmChurch & Dwight Inc
DistributionNationwide in the USA.
Quantity695,880 cartons
Recall initiated2025-06-06
Report date2025-07-09
Recall completed—
Recall numberD-0506-2025
ClassificationClass I
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.