Class I · High risk
Lactated Ringer's Irrigation
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
Ultra Zx Dietary Supplement
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Class I · High risk
Magnesium Sulfate in 5% Dextrose Injection
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Fentanyl Citrate
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Morphine Sulfate
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Bupivacaine HCl 0.0625%
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
iNSANE Bee Pollen capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
Class I · High risk
BtRiM Max capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.
Class I · High risk
AMPD GOLD Bee Pollen capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
Class I · High risk
iNDiGO capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Class I · High risk
EDGE Amplified Weight Release capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Class I · High risk
Avastin (Bevacizumab)
Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk
Avastin (Bevacizumab)
Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk
fentaNYL Citrate
Subpotent Drug
Class I · High risk
fentaNYL Citrate
Subpotent Drug
Class I · High risk
Practi-0.9% Sodium Chloride
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Class I · High risk
Slim-K
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Class I · High risk
Virginia Hospital Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.