Church & Dwight Inc drug recall: Zicam Cold Remedy Medicated Nasal Swabs
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97031
- Recall initiated
- Jun 6, 2025
- Classified by FDA
- Jul 3, 2025
- Posted in Enforcement Report
- Jul 9, 2025
- Recalling firm
- Church & Dwight Inc
- Firm location
- Princeton, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Press Release
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 6, 2025. FDA classified it 27 days later, on Jul 3, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide in the USA. Church & Dwight Inc has 12 recalls in our records.
Recalled products (3)
D-0504-2025 Class I Ongoing
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
Codes / lots: All lots.
Quantity: 3,374,918 cartons
D-0505-2025 Class I Ongoing
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Codes / lots: All Lots.
Quantity: 13,632 cartons
D-0506-2025 Class I Ongoing
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.
Codes / lots: All Lots.
Quantity: 695,880 cartons
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 97031
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.