Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class III · Low risk
Biotin 10 mg/mL Injection
Failed pH Specification: product does not meet pH label claim.
Class II · Moderate risk
Fayosim (levonorgestrel and ethinyl estradiol)
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class II · Moderate risk
Gavilyte-N
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk
Class III · Low risk
Diclofenac Sodium Topical Solution
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class III · Low risk
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15
Defective container: Ineffective seal between the cap and jar of the affected product.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter; glass particulates
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Clindamycin Injection
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk
Cleocin Phosphate
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class I · High risk
Blue Fusion Capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Class II · Moderate risk
Losartan 50mg Tablet
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 30 mg/30 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Heparin 5
Lack of Assurance of Sterility
Class II · Moderate risk
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Esmolol HCl Injectable Solution 100 mg/10 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
2% Lidocaine HCl Injectable Solution
Lack of Assurance of Sterility