Class I · High risk
Acyclovir Sodium Injection 1000mg/20mL
Crystallization: customer complaints for crystallization in finished product.
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class III · Low risk
Methacholine Challenge 5-Syringe Test Kits
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Class II · Moderate risk
Fludeoxyglucose F 18 Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Imatinib Mesylate Tablets 100mg
Failed Dissolution Specifications
Class I · High risk
Adam's Secret Extra Strength 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class I · High risk
Adam's Secret Extra Strength 1500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
Metoclopramide Injection USP
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Vecuronium Bromide for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Toposar (etoposide injection USP)
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Metoclopramide Injection USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
MethyIPREDNISolone Acetate Injectable Suspension USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Sterile Diluent for Epoprostenol Sodium for Injection
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Desmopressin Acetate Injection USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class II · Moderate risk
Dacarbazine for Injection USP
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Class III · Low risk
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion…
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications