Class III · Low risk
Quinapril Tablets USP
Subpotent Drug
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class II · Moderate risk
RIFAMPIN for Injection
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Colistimethate for Injection USP
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Droperidol injection
Presence of particulate.
Class II · Moderate risk
Promethazine Dm Syrup
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class II · Moderate risk
Ketorolac Trom 30 Mg/Ml Inj
Crystallization
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility; due to leaking vials
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing.
Class II · Moderate risk
Amlodipine Besylate Tablets USP
Failed tablet specifications: One lot was found to contain oversized tablets.
Class II · Moderate risk
Phen 15 mg - Topri 92 mg SR Cap
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Hydrocortisone 1.6 mg/0.5 mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Nystatin 50
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Coconut Oil Suppository
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Cyclandelate 200 mg Caps
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Triest 5 mg - Progest 150 mg Capsule
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Colchicine 0.6 mg Caps
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Lansoprazole 3 mg/mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Thymol 2% Solution
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Methenamine/Phenyl Salicylate Capsule
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.