ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ
Summary
The FDA issued a Class II for ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by Church & Dwight Co., Inc.. Reason: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient..
Details
Source
Drug Recall
External ID
D-0095-2026
Action Date
2025-10-29
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: BE51396303, Exp. Date 2027/05
Quantity Affected: 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.
Distribution
Product was distributed nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-01
Company
Ewing, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Church & Dwight Co., Inc. has 5 FDA actions in our database, including 1 recall and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Church & Dwight Co., Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Church & Dwight Co., Inc. have FDA actions?
Church & Dwight Co., Inc. has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0095-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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