FDAClass IJuly 9, 2025

Orajel Baby recall: Sterility Concern

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…

Why was Orajel Baby recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots.

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…
Recalling firm
Church & Dwight Inc
Quantity
695,880 cartons
Distribution
Nationwide in the USA.
Recall date
July 9, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
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