FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1117-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1116-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1115-2023

Class II · Moderate risk Terminated Aug 17, 2023

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1114-2023

Class II · Moderate risk Terminated Aug 17, 2023

rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. NDC 72196-6010-1 D-1113-2023

Class II · Moderate risk Terminated Aug 17, 2023

Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1112-2023

Class II · Moderate risk Terminated Aug 17, 2023

Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1111-2023

Class II · Moderate risk Terminated Aug 17, 2023

CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1110-2023

Class II · Moderate risk Terminated Aug 17, 2023

CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1109-2023

Class II · Moderate risk Terminated Aug 17, 2023

CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1108-2023

Class II · Moderate risk Terminated Aug 17, 2023

CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture…

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1107-2023

Class II · Moderate risk Terminated Aug 15, 2023

NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

Reason Lack of Assurance of Sterility

TMC Acquisitions LLC dba Tailor Made Compounding D-1106-2023

Class II · Moderate risk Terminated Aug 15, 2023

Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

Reason Lack of Assurance of Sterility

TMC Acquisitions LLC dba Tailor Made Compounding D-1105-2023

Class II · Moderate risk Terminated Aug 11, 2023

Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured…

Reason Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Avkare LLC NDC 50268-195-60 D-1147-2023

Class II · Moderate risk Terminated Aug 11, 2023

Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET…

Reason Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled…

Avkare LLC NDC 42291-741-51 D-1146-2023

Class II · Moderate risk Terminated Aug 11, 2023

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only…

Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation NDC 0941-0411-07 D-1141-2023

Class II · Moderate risk Terminated Aug 11, 2023

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag…

Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation NDC 0941-0409-06 D-1140-2023

Class II · Moderate risk Terminated Aug 10, 2023

hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by…

Reason Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were…

Colgate Palmolive Company D-1084-2023

Class II · Moderate risk Terminated Aug 2, 2023