Orajel Baby teething swabs recalled over fungal contamination of swabs
Orajel Baby Cooling Swabs for Teething are being recalled because of fungal contamination of the infant oral swabs. All lots are affected, covering 695,880 cartons.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no illness is reported in the source, so it does not escalate to Critical.
Plain-English summary
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. of Ewing, New Jersey, UPC 3 10310 40000 2, is being recalled. The action covers 695,880 cartons and applies to all lots.
The stated reason is microbial contamination of non-sterile products: fungal contamination of the infant oral swabs. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the USA. The product is sold over the counter for use in infants.
Parents and carers who have the product should stop using it and follow the instructions issued by the manufacturer. Anyone whose child has used it and appears unwell should seek medical advice.
The recalled product
- 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.
- Manufacturer
- Church & Dwight Inc
- Category
- Drug — Infant oral swab
- Hazard
- microbial-contamination
- fungal-contamination
- infant-product
- non-sterile-product
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots.
Distribution
Distributed nationwide across the United States.
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