US Drug Recall Register

FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated

Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu

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 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.

Reckitt Benckiser LLC NDC 63824-528-22 D-1368-2015
Class I · High risk Terminated

Mucinex Fast Max Severe Congestion & 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 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.

Reckitt Benckiser LLC NDC 63824-014-66 D-1367-2015
Class I · High risk Terminated

Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time…

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 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.

Reckitt Benckiser LLC NDC 63824-526-22 D-1366-2015
Class I · High risk Terminated

Mucinex Fast-Max Cold & Sinus

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 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.

Reckitt Benckiser LLC NDC 63824-016-66 D-1365-2015
Class I · High risk Terminated

Mucinex Fast Max Night Time Cold & Flu

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 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.

Reckitt Benckiser LLC NDC 63824-500-66 D-1364-2015
Class I · High risk Terminated

Mucinex Fast Max Cold

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 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.

Reckitt Benckiser LLC NDC 63824-015-66 D-1363-2015
Class I · High risk Terminated

EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP

Reason 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.

Pharmedium Services, LLC NDC 61553-119-61 D-1358-2015
Class I · High risk Terminated

HEPARIN Sodium Injection USP 25

Reason 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.

Pharmedium Services, LLC NDC 61553-419-02 D-1357-2015
Class I · High risk Terminated

EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP

Reason 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.

Pharmedium Services, LLC NDC 61553-618-61 D-1356-2015
Class I · High risk Terminated

HEPARIN Sodium Injection USP

Reason 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.

Pharmedium Services, LLC NDC 61553-418-02 D-1355-2015
Class I · High risk Terminated

EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP

Reason 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.

Pharmedium Services, LLC NDC 61553-244-61 D-1354-2015
Class I · High risk Terminated

oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP

Reason 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.

Pharmedium Services, LLC NDC 61553-777-02 D-1353-2015
Class I · High risk Terminated

Testosterone Cypionate 200 mg/mL in Sesame oil

Reason 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.

Stroheckers Inc Pharmacy D-1088-2015
Class I · High risk Terminated

Lactated Ringers Injection

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0117-02 D-1211-2015
Class I · High risk Terminated

10% Dextrose Injection

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0023-02 D-1210-2015
Class I · High risk Terminated

5% Dextrose Injection

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0017-02 D-1209-2015
Class I · High risk Terminated

0.9% Sodium Chloride Injection

Reason Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Baxter Healthcare Corp. NDC 0338-0049-02 D-1208-2015
Class I · High risk Terminated

Gemcitabine for Injection

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-462-01 D-1334-2015
Class I · High risk Terminated

Gemcitabine for Injection

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-463-02 D-1333-2015
Class I · High risk Terminated

Gemcitabine for Injection

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-464-20 D-1332-2015
Class I · High risk Terminated

CARBOplatin Injection 450 mg/45 mL

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 67457-493-46 D-1331-2015
Class I · High risk Terminated

Methotrexate Injection

Reason Presence of Particulate Matter

Mylan Institutional LLC NDC 0069-0146-01 D-1328-2015
Class I · High risk Terminated

Lactated Ringer's Irrigation

Reason Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold

Hospira Inc. NDC 0409-7828-08 D-1108-2015
Class I · High risk Terminated

Ultra Zx Dietary Supplement

Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein

Ultra ZX Supplements D-0991-2015
Class I · High risk Terminated

Magnesium Sulfate in 5% Dextrose Injection

Reason 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.

Hospira Inc. NDC 0409-6727-23 D-1076-2015