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Lower risk Drug recall · FDA · Published June 6, 2025

Orajel Baby Swabs Recall: Fungal Contamination Risk for Infants

Church & Dwight recalls Orajel Baby teething swabs due to fungal contamination. Infants using these swabs may face health risks from the contamination. Consumers should check product details and follow official recall instructions.

🇺🇸 FDA recall #D-0506-2025DrugChurch & Dwight ›
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Recalling firmChurch & Dwight Inc469 N Harrison St · Princeton, NJ 08540-3510
✎ GovInfoNow plain-language explainer

Church & Dwight is recalling Orajel Baby teething swabs because they were contaminated with fungi. This poses a health risk to infants who use the swabs, as fungal infections can cause serious illness in babies. Read more at govinfonow.com/recall/32031-orajel-baby-swabs-recall-fungal-contamination-risk-for-infants.

Source Summary by GovInfoNow · govinfonow.com/recall/32031-orajel-baby-swabs-recall-fungal-contamination-risk-for-infants · Updated August 17, 2026 · FDA enforcement record: FDA #D-0506-2025

Cite this page

“Orajel Baby Swabs Recall: Fungal Contamination Risk for Infants.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32031-orajel-baby-swabs-recall-fungal-contamination-risk-for-infants. Based on FDA recall #D-0506-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0506-2025%22&limit=1).

Church & Dwight Inc recalled Orajel Baby Cooling Swabs for Teething due to fungal contamination, according to the FDA. The agency announced the voluntary Class I recall on June 6, 2025.

How to tell if you have it

  • Orajel Baby, Cooling Swabs for Teething
  • UPC 00310310400002
  • All Lots

The hazard

The recall addresses microbial contamination of non-sterile products, specifically fungal contamination of the infant oral swabs.

Context

GovInfoNow's records show Church & Dwight Inc has five other recalls on record since September 6, 2012. Other recent recalls include a TheraBreath for Kids recall dated September 8, 2023, and a First Response Pregnancy Test Sticks recall dated January 25, 2023. Similar recent recalls of comparable items include Zicam Cold Remedy Nasal Swabs (August 10, 2026), Zep Alcohol Sanitizer Spray (May 22, 2026), and CareFusion BD ChloraPrep Triple Swabsticks (December 17, 2025).

How to tell if you have this one

Check for the product name 'Orajel Baby, Cooling Swabs for Teething' with 12 single-use swabs per carton. The UPC code is 3 10310 40000 2. All lots of this product are affected.

  • Brand
    Church & Dwight
  • 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
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Nationwide in the USA.
Recall numberProduct, codes & lotsQuantity
D-0504-2025ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5; All lots.3,374,918 cartons
D-0505-2025ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6; All Lots.13,632 cartons
D-0506-2025Orajel 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.; All Lots.695,880 cartons
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product name 'Orajel Baby, Cooling Swabs for Teething' with 12 single-use swabs per carton and UPC code 3 10310 40000 2.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Jun 6, 202512. FDA classified it Class I: Jul 3, 202523. Published in FDA’s Enforcement Report: Jul 9, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0506-2025 (June 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0506-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA