Class II · Moderate risk
Medline Remedy Specialized Silicone Cream
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
FDA drug recalls in 2026
Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
563 recalls, newest first.
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
ChloraPrep FREPP
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Clear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Class II · Moderate risk
Imuldosa
Lack of assurance of Sterility:
Class II · Moderate risk
Lidocaine HCl Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Accucaine
Lack of Assurance of Sterility
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Methohexital Sodium for Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Class II · Moderate risk
Povi-One
sub potency
Class II · Moderate risk
Lacosamide Tablets
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Class II · Moderate risk
Corlanor (ivabradine)
Presence of Foreign Substance.
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations