Class I · High risk
Methylprednisolone Acetate
Non-Sterility
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Methylprednisolone Acetate
Non-Sterility
Class II · Moderate risk
Lactated Ringer's Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
5% Dextrose and 0.45% Sodium Chloride Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
10% Dextrose Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
5% Dextrose Injection USP
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Class II · Moderate risk
Limed Bone Gelatin
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Class I · High risk
SLIM XTREME Herbal Slimming Capsule
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Class II · Moderate risk
Nutropin AQ NuSpin 10
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Class II · Moderate risk
Nutropin AQ NuSpin 20
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Class III · Low risk
Children's Cetirizine HCl Chewable Tablets 5 mg
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Class II · Moderate risk
UP & UP brand
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Class II · Moderate risk
UP & UP brand
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class I · High risk
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class II · Moderate risk
Orajel Kids My Way! Anticavity Fluoride
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
Class II · Moderate risk
Cymevene 500 mg Powder for Infusion
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Class III · Low risk
Enalapril Maleate Tablet
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Class II · Moderate risk
DRxChoice Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Premier Value Fiber Plus Calcium Supplement Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Premier Value Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Class II · Moderate risk
Simply Right Healthcare Fiber Capsules
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.