Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Jul 14, 2023 TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextro... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low trometham... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, I... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total v... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, to... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged b... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV B... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CAL... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Cent... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total vol... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixtu... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CAL... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextros... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIU... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx o... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Centr... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium,... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Centa... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CA... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, R... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200m... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Po... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Ce... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV B... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextros... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total v... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total vol... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 un... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassiu... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx On... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium,... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, I... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CAL... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Ba... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEP... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low c... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIU... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethami... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.