ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY
Recalling Firm / Manufacturer: Church & Dwight Co., Inc.
(Ewing, NJ, United States)
FDA Recall Number: D-0095-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY
Generic Name
ZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP
Active Substance(s)
Zinc Acetate Anhydrous, Zinc Gluconate, Sambucus Nigra Flowering Top
Administration Route
Oral
National Drug Code (NDC)
10237-469
Total Quantity Recalled
21,912 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Full Product Description
Packaging specifications and labeling details
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 29, 2025
Firm Initiation Date
October 01, 2025
FDA Classification Date
Oct 22, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot#: BE51396303, Exp. Date 2027/05
Distribution Information
Geographic scope of affected shipments
Product was distributed nationwide within the United States
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0095-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508611UTCC