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…
Read the official notice →- Date
- 2023-04-19
- Country
- United States
- Brand
- Church & Dwight
- Product
- Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text…
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
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 Details may be shortened or out of date; the official notice is the authoritative source.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
- US
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
- US
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.
- US
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.
- 2023-10-25
- US
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
Other drugs & medical recalls in the United States
- 2023-04-19
- US
Shanghai United Imaging Healthcare Co., Ltd. recalls Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model…
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.Official notice → - US
Merit Medical Systems, Inc. recalls Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Product that was built for design verification testing was inadvertently distributed to customers.
FDA · DeviceMerit Medical Systems, Inc.U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/AOfficial notice → - US
Outset Medical, Inc. recalls Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis…
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO,…Official notice → - US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
FDA · DeviceFresenius Kabi USA, LLCDomestic: CA, CO, NJ, WI, & UT. No foreign distribution.Official notice → - US
Focus Health Group Inc recalls Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus…
Labeling; Incorrect NDC number on outer carton of product.
- US
Pfizer Inc. recalls MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer…
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.