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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 695,880
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.
Part of a larger recall action
This product is one of 3 recalled by Church & Dwight Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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