October 2025 FDA Recall Zicam Cold Remedy Medicated Fruit Drops - Elderberry by Church & Dwight Co., Inc.
D-0095-2026 - Labeling

This Class II drug recall was voluntarily initiated by Church & Dwight Co., Inc. on October 1, 2025 for the product Zicam Cold Remedy Medicated Fruit Drops - Elderberry. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0095-2026

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
10-01-2025
Reported
10-29-2025
Quantity
21,912 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97729
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Church & Dwight Co., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide within the United States
Product Description About Product Description
Full technical description of the product.
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

10237-469-25 Zicam Cold Remedy Medicated Fruit Drops - Elderberry
10237-469-22 Zicam Cold Remedy Medicated Fruit Drops - Elderberry