Class II · Moderate risk
Heparin Sodium
Subpotent: Low anti-factor IIa Potency.
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class III · Low risk
Methylprednisolone Acetate Injectable Suspension
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Class II · Moderate risk
Buprenorphine Sublingual Tablets
CGMP Deviations
Class II · Moderate risk
Safe tussin PM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Pin-Away PYRENTAL PAMOATE
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Colic Calm
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Safe tussin DM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL 500 mcg
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL 50 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Succinylcholine Cl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Famotidine Tablets
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk
Pyrazinamide
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.