Class I · High risk
Adventist Hinsdale Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
Adventist Hinsdale Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Bridgeport Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
The Medical Center of Aurora
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
University of Alabama Birmingham TPN Neonatal Starter Bag
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Professional Formexx Black
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Swoll-250 Super Mass Builder Quad Stack
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Estrastain Pro-Anabolic Mass and Hardening Complex
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
7-Ment Alpha Advanced Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Halo-70 Mega Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
M14-Ment Advanced Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
M1-Alpha Labs Mega Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Class I · High risk
MitoXANTRONE Injection
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Class I · High risk
Forever Beautiful BEE POLLEN
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Class I · High risk
Forever Beautiful INFINITY
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Class I · High risk
1% LIDOCAINE HCl Injection
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Class I · High risk
Propofol Injectable Emulsion
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I · High risk
Heparin Sodium
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Class I · High risk
Tropi/Cyclo/Phenyl/Tobra/Flurb
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk
Magnesium Chloride 20%
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class I · High risk
Glutathione 100mg/mL Sterile Injection
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.