Class II · Moderate risk
Glutathione 100 mg/mL Inhalation Solution
Lack of Assurance of Sterility.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
Chorionic Gonadotropin 2
Lack of Assurance of Sterility.
Class II · Moderate risk
PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Methylcobalamin 10 mg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Methylcobalamin 1 mg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Hydroxocobalamin 10 mg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Prostaglandin 20 mcg/mL/Procaine 0.1% Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Testosterone Cypionate 100 mg/mLOil Injection Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL Sesame Oil Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Testosterone Cypionate 150 mg/mL Sesame Oil Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Testosterone Cypionate 100 mg/mL Sesame Oil Injection
Lack of Assurance of Sterility.
Class III · Low risk
Smart Sense Regular Strength Aspirin Tablets
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Class II · Moderate risk
Diphenhydramine HCL Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Acetaminophen Children's Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Workvie Instant Pain Relieving Roll On
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Neogen-D
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Sorbugen Nr
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Tusslin
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Dayma SUPER FORTE XL10
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.