Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
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
fentaNYL Citrate
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Class I · High risk
Akttive High Performance Fat Burner Gold dietary supplement capsules
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Class I · High risk
Zero Xtreme High Performance Fat Burner capsules
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Class I · High risk
PYROLA Advanced Joint Formula capsules
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Class I · High risk
Smart Lipo Dietary Supplement capsules
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Class I · High risk
Smart Lipo Dietary Supplement capsules
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Class I · High risk
Morphine Sulfate
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Class I · High risk
Adrucil (fluorouracil injection, USP)
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class I · High risk
Cytarabine Injection 100 mg/5 mL
Presence of Particulate Matter
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Class I · High risk
Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Severe Congestion & Cough
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast-Max Cold & Sinus
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Night Time Cold & Flu
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Cold
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP 25
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
Testosterone Cypionate 200 mg/mL in Sesame oil
Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20 mg/mL.
Class I · High risk
Lactated Ringers Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)