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Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL)...

FDA Recall #D-0506-2025 — Class I — June 6, 2025

Recall #D-0506-2025 Date: June 6, 2025 Classification: Class I Status: Ongoing

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.

Reason for Recall

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

Recalling Firm

Church & Dwight Inc — Princeton, NJ

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

695,880 cartons

Distribution

Nationwide in the USA.

Code Information

All Lots.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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