Church & Dwight Inc recalls TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6…
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Read the official notice →- Date
- 2023-10-25
- Country
- United States
- Brand
- Church & Dwight
- Product
- TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6…
- Classification
- Class I
- Units
- Nationwide in the US
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Church & Dwight recalls
- 2026-09-02
USChurch & Dwight Co., Inc. recalls Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic,…
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
- 2025-10-29
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Church & Dwight Co., Inc. recalls ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC…
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
FDA · DrugChurch & Dwight Co., Inc.Product was distributed nationwide within the United StatesOfficial notice → - 2025-07-09
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Church & Dwight Inc recalls Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton,…
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
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Church & Dwight Inc recalls ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216…
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
- 2023-04-19
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Church & Dwight Inc recalls Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text…
Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the…
Other drugs & medical recalls in the United States
- 2023-10-25
- US
KVK-Tech, Inc. recalls Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
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Baxter Healthcare Corporation recalls Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter…
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
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VistaPharm LLC recalls Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by:…
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
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Dollar Tree Distribution, Inc. recalls Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
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Imprimis NJOF, LLC recalls MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle,…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
FDA · DrugImprimis NJOF, LLCProduct was distributed to physician's offices nationwide.Official notice →