Zicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
Church & Dwight is recalling Zicam Cold Remedy Nasal Swabs because FDA inspections found out-of-limit microbiological testing results at the contract manufacturer.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the microbiological testing failures that pose a risk of harm.
Plain-English summary
Church & Dwight Co., Inc. is recalling 318,600 cartons of Zicam Cold Remedy Medicated Nasal Swabs. The affected products are the 20 single-use swab cartons with cooling menthol and eucalyptus, distributed nationwide in the United States. The recall involves specific lots with expiration dates in 2028.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection of the contract manufacturer. The inspection noted out-of-limit results for microbiological testing, indicating potential contamination or quality control issues.
Consumers who have purchased these specific lots of Zicam nasal swabs should stop using them and return the product to the place of purchase for a refund or contact the manufacturer for further instructions.
The recalled product
- Product
- Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
- Manufacturer
- Church & Dwight Co., Inc.
- Category
- Drug — OTC Nasal Decongestant
- Affected units
- 318,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # UN52882
- Exp Date: 04/30/2028
- Lot # UN53431
- Exp Date: 06/30/2028
- Lot # UN60411
- Exp Date: 08/31/2028.
Distribution
Distributed nationwide across the United States.
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