FDA Drug Recalls

Recalls / Class II

Class IID-0095-2026

Product

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

Brand name
Zicam Cold Remedy Medicated Fruit Drops - Elderberry
Generic name
Zinc Acetate Anhydrous, Zinc Gluconate, And Sambucus Nigra Flowering Top
Active ingredients
Sambucus Nigra Flowering Top, Zinc Acetate Anhydrous, Zinc Gluconate
Route
Oral
NDC
10237-469
Affected lot / code info
Lot#: BE51396303, Exp. Date 2027/05

Why it was recalled

Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.

Recalling firm

Firm
Church & Dwight Co., Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
500 Charles Ewing Blvd, Ewing, New Jersey 08628-3448

Distribution

Quantity
21,912 bottles
Distribution pattern
Product was distributed nationwide within the United States

Timeline

Recall initiated
2025-10-01
FDA classified
2025-10-22
Posted by FDA
2025-10-29
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0095-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.