FDA Recall D-0095-2026

Church & Dwight Co., Inc. · Ewing, NJ

Class II Ongoing 225 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25

Lot / code: Lot#: BE51396303, Exp. Date 2027/05

Quantity: 21,912 bottles

Reason for recall

Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.

Recall record

Recall number: D-0095-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed nationwide within the United States
Recall initiated: 2025-10-01
Classified by FDA Center: 2025-10-22
FDA published: 2025-10-29
Recalling firm: Church & Dwight Co., Inc.
Firm location: Ewing, NJ

Drug identification

Brand name(s): ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY
Generic name(s): ZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP
Manufacturer(s): Church & Dwight Co., Inc.
NDC(s): 10237-469
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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