Class II · Moderate risk
Hydroxocobalamin 10 mg/mL Injection
Lack of Assurance of Sterility.
FDA Drug Recalls
18,003 recalls, newest first
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.
Class II · Moderate risk
Lid O Creme
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
Lido E.R. (Lidocaine HCL 4%)
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
Dermanak original crema blanqueador
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
LidoAID (Lidocaine HCL 4%)
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
Double Tussin Dm
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
Gencontuss
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
ARMY HEALTH Pain Reliever Gel With CURCUMIN
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
Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.