Drug Enforcement D-0506-2025

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

Status

Ongoing

Classification

Class I

Report Date

July 9, 2025

Termination Date

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Product Information

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.
Product quantity
695,880 cartons
Reason for recall
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Church & Dwight Inc
Address
469 N Harrison St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0506-2025
Event ID
97031
Recall initiation date
June 6, 2025
Center classification date
July 3, 2025
Code info
All Lots.
More code info
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