Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported July 9, 2025
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.
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Church & Dwight Inc recalled Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ … - a critical-severity action.
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ … was recalled by Church & Dwight Inc in July 9, 2025. Reason: Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.. Check the official notice for the remedy. Verify recall #D-0506-2025 with the FDA Drug before acting.
The recall
Church & Dwight Inc issued this critical-severity FDA Drug recall-Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs..
- Critical
- severity level
- Class I
- classification
- July 9, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0506-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0506-2025) was formally reported on July 9, 2025, with the manufacturer initiating the action on June 6, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Church & Dwight Inc is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 695,880 cartons.
The documented reason for this recall is: Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. Distribution data in the federal record shows the product reached: Nationwide in the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
695,880 cartons
Related Recalls
6
0 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0506-2025 |
| Date reported | July 9, 2025 |
| Date initiated | June 6, 2025 |
| Recalling firm | Church & Dwight Inc |
| Firm location | Princeton, NJ |
| Affected scope | 695,880 cartons |
| Distribution | Nationwide in the USA. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0506-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Church & Dwight Inc. Units affected: 695,880 cartons.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 9, 2025. Severity: Critical. Recall number: D-0506-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0506-2025) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 9, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.