Drug FDA Class II Ongoing Mislabeling

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

Church & Dwight Co., Inc. Published Oct 29, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Church & Dwight Co., Inc. or your place of purchase with questions, and see the source record below for full details.

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.

Hazards

Elderberry not listed on label · primary

Affected products (1)

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

ZICAM COLD REMEDY MEDICATED FRUIT DROPS - ELDERBERRY · 21,912 bottles

NDC: 10237-469, 10237-469-25, 10237-469-22

Code info: Lot#: BE51396303, Exp. Date 2027/05

Affected areas

Nationwide

Timeline

Initiated

Oct 1, 2025
Published

Oct 29, 2025

Recall number: D-0095-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.