CLASS I ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
Zicam Cold Remedy Medicated Nasal Swabs-Use Swabs recalled
Church & Dwight is recalling Zicam Cold Remedy Medicated Nasal Swabs-Use Swabs per, distributed nationwide in the US. The recall was initiated on 6 Jun 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0504-2025
- FDA event ID
- 97031
- Recalling firm
- Church & Dwight, Princeton, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 6 Jun 2025
- FDA classified
- 3 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Nasal Sprays
Timeline
| 6 Jun 2025 | Recall initiated by company | |
| 3 Jul 2025 | Classified by FDA | +27 days |
| 9 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Which lots are affected?
All lots.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97031This product is part of a recall event; the main page for the event is Orajel Baby, Cooling Swabs for Teething, Each Unit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Orajel Baby, Cooling Swabs for Teething, Each Unit recalled | Church & Dwight | Sterility | Nationwide | |
| CLASS I | Zicam Nasal All recalled by Church & Dwight | Church & Dwight | Sterility | Nationwide |
More recalls from Church & Dwight
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zicam, Cold Remedy, Medicated Nasal Swabs recalled by Church & Dwight Co | Church & Dwight | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zicam" Medicated Fruit Drops Elderberry Flavor, 25-drops recalledZicam Cold Remedy Medicated Fruit Drops - Elderberry | Church & Dwight | Packaging Defects | Nationwide |
| Drug | CLASS I | Zicam Nasal All recalled by Church & Dwight | Church & Dwight | Sterility | Nationwide |
| Drug | CLASS I | Orajel Baby, Cooling Swabs for Teething, Each Unit recalled | Church & Dwight | Sterility | Nationwide |
| Drug | CLASS I | TheraBreath for Kids! Oral Rinse, sodium fluoride recalled | Church & Dwight | Mold | Nationwide |