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 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
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.
Class I · High risk
Ascorbic Acid 500 mg/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.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Class I · High risk
Dianeal Low Calcium
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Class I · High risk
Epel 18 mg Estradiol Pellet
Non-Sterility: The recalled lot failed sterility testing.
Class I · High risk
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Class I · High risk
Potassium Chloride Injection
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk
LACTATED RINGER'S and 5% DEXTROSE Injection USP
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Class I · High risk
Oxcarbazepine Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Class I · High risk
Ibuprofen Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Class I · High risk
Ascorbic Acid 500 mg/mL Sterile Injection
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class I · High risk
Soliris (eculizumab)
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Class I · High risk
LOW Potassium Cardioplegia 792 mL
Non Sterility; microbial contamination identified as Aspergillus species