Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Orajel Baby
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What 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.
- Recalling firm
- Church & Dwight Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jun 6, 2025 · FDA notice with lot numbers
- FDA recall number
- D-0506-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other recalls by Church & Dwight Inc
All 2025 recalls
Class II · Moderate risk
Zicam" Medicated Fruit Drops Elderberry Flavor
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class I · High risk
Zicam Nasal Allclear
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk
Zicam Cold Remedy Medicated Nasal Swabs
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Other microbial contamination recalls from 2025
All microbial contamination recalls
Class I · High risk
ClearLife Allergy Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I · High risk
ReBoost Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class II · Moderate risk
Walgreens Saline Nasal Spray WITH XYLITOL
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class I · High risk
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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