Class I · High risk
Walter Reed Natl Mil Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I drug recalls - the high-risk category
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Class I · High risk
Walter Reed Natl Mil Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Sinai Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Holy Cross Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Olathe Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Methodist Hospital Northlake
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Advocate Good Samaritan Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Advocate Good Samaritan Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Adventist Hinsdale Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
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.