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FDA Drug Recalls

1,122 recalls, newest first

Class II · Moderate risk Terminated Nov 10, 2023

PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90…

Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori…

Golden State Medical Supply Inc. NDC 60429-737-30 D-0130-2024

Class II · Moderate risk Terminated Nov 10, 2023

PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only…

Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori…

Golden State Medical Supply Inc. NDC 60429-735-90 D-0129-2024

Class II · Moderate risk Terminated Nov 10, 2023

PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90…

Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori…

Golden State Medical Supply Inc. NDC 60429-734-30 D-0128-2024

Class III · Low risk Terminated Nov 10, 2023

Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA…

Reason OOS for viscosity

Teva Pharmaceuticals USA, Inc NDC 0591-2926-30 D-0127-2024

Class III · Low risk Ongoing Nov 10, 2023

Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For…

Reason Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

Fagron Compounding Services NDC 71266-8240-01 D-0125-2024

Class II · Moderate risk Terminated Nov 9, 2023

VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0923-59 D-0425-2024

Class II · Moderate risk Terminated Nov 9, 2023

SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0908-09 D-0424-2024

Class II · Moderate risk Terminated Nov 9, 2023

SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0908-12 D-0423-2024

Class II · Moderate risk Terminated Nov 9, 2023

Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0900-25 D-0422-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0816-12 D-0421-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0816-12 D-0420-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0825-40 D-0419-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0811-12 D-0418-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0810-22 D-0417-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0810-11 D-0416-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0810-11 D-0415-2024

Class II · Moderate risk Terminated Nov 9, 2023

PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0810-12 D-0414-2024

Class II · Moderate risk Terminated Nov 9, 2023

neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0750-09 D-0413-2024

Class II · Moderate risk Terminated Nov 9, 2023

Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0411-59 D-0412-2024

Class II · Moderate risk Terminated Nov 9, 2023

labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0700-28 D-0411-2024

Class II · Moderate risk Terminated Nov 9, 2023

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0303-21 D-0410-2024

Class II · Moderate risk Terminated Nov 9, 2023

HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0303-16 D-0409-2024

Class II · Moderate risk Terminated Nov 9, 2023

HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0303-17 D-0408-2024

Class II · Moderate risk Terminated Nov 9, 2023

HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0300-22 D-0407-2024

Class II · Moderate risk Terminated Nov 9, 2023

HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755…

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0300-18 D-0406-2024