DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl recall — FDA D-0422-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
Recall records from May 2025
These records include useful source details for the selected month.
DrugMay 28, 2025
CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0441-2025
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class IIFDA: OngoingCareFusion 213, LLC
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold recall — FDA D-0430-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KOFAL recall — FDA D-0426-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
RAPIDOL recall — FDA D-0429-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE KOFAL Original, Penetrating Pain Relieving Ointment recall — FDA D-0425-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 recall — FDA D-0423-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Nature Mint, Anticavity Fluoride Toothpaste, Sodium recall — FDA D-0437-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Nature Mint, Anticavity Fluoride Toothpaste, Sodium recall — FDA D-0436-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22% recall — FDA D-0433-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose recall — FDA D-0442-2025
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term…
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22% recall — FDA D-0432-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Nature Mint, Anticavity Fluoride Toothpaste, Sodium recall — FDA D-0435-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) recall — FDA D-0424-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube recall — FDA D-0428-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
Artridon Glucosamine recall — FDA D-0421-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External recall — FDA D-0427-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22% recall — FDA D-0431-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose recall — FDA D-0443-2025
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term…
Class IIFDA: OngoingZydus Pharmaceuticals (USA) Inc
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22% recall — FDA D-0434-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Nature Mint, Anticavity Fluoride Toothpaste, Sodium recall — FDA D-0440-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Nature Mint Anticavity Fluoride Toothpaste, Sodium recall — FDA D-0439-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
DrugMay 28, 2025
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation recall — FDA D-0444-2025
Defective delivery system
Class IIFDA: OngoingAsttraZeneca Pharmaceuticals LP
DrugMay 28, 2025
KENIL HEALTHCARE PRIVATE Nature Mint Anticavity Fluoride Toothpaste, Sodium recall — FDA D-0438-2025
CGMP Deviations
Class IIFDA: TerminatedKENIL HEALTHCARE PRIVATE LIMITED
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.