Zicam fruit drops recalled because label omitted elderberry as an ingredient
Church & Dwight is recalling 21,912 bottles of Zicam Medicated Fruit Drops Elderberry Flavor because the label failed to list elderberry as an ingredient.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a labelling error: elderberry is not among the common allergens the rubric places at 3, and no injury is reported.
Plain-English summary
ZICAM Medicated Fruit Drops Elderberry Flavor, 25 drops per bottle, distributed by Church & Dwight of Ewing, New Jersey, is being recalled for a label mix-up. The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
The recall covers 21,912 bottles from lot BE51396303, expiring May 2027, carrying NDC 10237-469-25. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record describes the labelling omission only and reports no injuries.
Anyone holding a bottle from the affected lot should follow the retailer's instructions.
The recalled product
- Product
- ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY (ZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP)
- Brand
- ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY
- Manufacturer
- Church & Dwight Co., Inc.
- Category
- Drug — Cold remedy
- Affected units
- 21,912
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 (2)
- Lot#: BE51396303
- Exp. Date 2027/05
UPCs (1)
- 0732216301564
Distribution
Distributed nationwide across the United States.
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