FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk Terminated Apr 28, 2015

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use…

Reason Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and…

Teva Pharmaceuticals USA NDC 0703-3019-11 D-1089-2015

Class I · High risk Terminated Apr 23, 2015

Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton…

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 0069-0152-01 D-1329-2015

Class I · High risk Terminated Apr 23, 2015

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE…

Reason Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Hospira Inc. D-1216-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total…

Reason 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…

Reckitt Benckiser LLC NDC 63824-528-22 D-1368-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant…

Reason 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…

Reckitt Benckiser LLC NDC 63824-014-66 D-1367-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360…

Reason 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…

Reckitt Benckiser LLC NDC 63824-526-22 D-1366-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant…

Reason 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…

Reckitt Benckiser LLC NDC 63824-016-66 D-1365-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl…

Reason 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…

Reckitt Benckiser LLC NDC 63824-500-66 D-1364-2015

Class I · High risk Terminated Apr 15, 2015

Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough…

Reason 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…

Reckitt Benckiser LLC NDC 63824-015-66 D-1363-2015