Zicam Cold Remedy Medicated Fruit Drops - Elderberry Bar, Chewable
FDA Recall NDC 10237-469

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Zicam Cold Remedy Medicated Fruit Drops - Elderberry (NDC 10237-469). A significant event, classified as Class II, was initiated on Oct 01, 2025 by Church & Dwight Co., Inc.. The reported reason for this action was: "Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

October 2025 Class II Recall: Labeling

Recall Number
Class II Ongoing
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.
Initiated
Oct 01, 2025
Reported
Oct 29, 2025
Quantity
21,912 bottles

Recall Profile & Regulatory Data

Event ID
97729
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Church & Dwight Co., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States
Product Description
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Batch or Lot Expiration Information
Lot# : BE51396303, Exp. Date 2027/05
Affected Packages Involved in this Recall
10237-469-25Product
10237-469-22Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.