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Browse Drug Recalls

329 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 329 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 329 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 1.75g 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 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, 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 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%, 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% 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%/Dextrose 10% with **low... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High 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 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 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 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 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 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low... 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 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 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, 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 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 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 oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Centra... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/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 succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repa... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, 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) 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 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/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 oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, 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, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High P... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/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 dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, 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 glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, 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 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 heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/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, 60 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 dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, 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 heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, R... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 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 norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 ... 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.