CLASS II ONGOING Drug recall · Reported 29 Oct 2025 · FDA Enforcement Report
Zicam" Medicated Fruit Drops Elderberry Flavor, 25-drops recalled
Church & Dwight is recalling Zicam" Medicated Fruit Drops Elderberry Flavor, 25-drops per, distributed nationwide in the US. The recall was initiated on 1 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0095-2026
- FDA event ID
- 97729
- Recalling firm
- Church & Dwight, Ewing, NJ
- Manufacturer
- Church & Dwight Co., Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Oct 2025
- FDA classified
- 22 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 1 Oct 2025 | Recall initiated by company | |
| 22 Oct 2025 | Classified by FDA | +21 days |
| 29 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Where it was distributed
Product was distributed nationwide within the United States
Questions about this recall
Why was it 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.
Which lots are affected?
Lot#: BE51396303, Exp. Date 2027/05
Where was it sold?
Product was distributed nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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