Class II · Moderate risk
Fentanyl Citrate Active Pharmaceutical Ingredient
cGMP Deviations: Potential glass contamination
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
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg
Failed Stability Specifications.
Class II · Moderate risk
Ascorbic Acid Sterile Injection Solution
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Class III · Low risk
Lamivudine Tablets
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Class III · Low risk
minolira (minocycline hydrochloride)
Failed Dissolution Specifications:
Class II · Moderate risk
Entropic Labs SARM RAD-140
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Wal-Fex (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy (Fexofenadine Hydrochloride)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine HCL Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
fexofenadine hydrochloride tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Allergy Relief
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Fexofenadine Hydrochrloride Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Class II · Moderate risk
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use
Lack of Assurance of Sterility.
Class II · Moderate risk
RELPAX (eletriptan HBr)
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Class II · Moderate risk
S-TRIMIX various strengths to include:a) S-TRIMIX
Lack of Assurance of Sterility
Class II · Moderate risk
S-TRIMIX (29.4mg/0.98mg/9.8mcg/Ml)
Lack of Assurance of Sterility
Class II · Moderate risk
S-TRIMIX (40mg/2.5mg/29mcg)
Lack of Assurance of Sterility
Class II · Moderate risk
S-TRIMIX (15mg/0.5mg/16mcg/Ml)
Lack of Assurance of Sterility