Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Zicam" Medicated Fruit Drops Elderberry Flavor
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Affected NDC
10237-0469-25
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zicam Cold Remedy Medicated Fruit Drops - Elderberry zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top NDC 10237-0469 |
ZINC ACETATE ANHYDROUS 2 [hp_X]/1; ZINC GLUCONATE 2 [hp_X]/1; SAMBUCUS NIGRA FLOWERING TOP 4 [hp_X]/1 | Bar, Chewable Oral |
Church & Dwight Co., Inc. | OTC |
- Recalling firm
- Church & Dwight Co., Inc.
- NDC code
- 10237-469-25
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0095-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Church & Dwight Co., Inc.
All 2025 recalls
Class I · High risk
Orajel Baby
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I · High risk
Zicam Nasal Allclear
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk
Zicam Cold Remedy Medicated Nasal Swabs
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Other labeling / mix-up recalls from 2025
All labeling / mix-up recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class III · Low risk
parodontax
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg / 5 mL
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
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