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
Dec 17, 2014 Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Addi... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextros... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, T... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neona... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextro... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamin... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acid... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Tropha... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , D... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, A... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 1... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Tr... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additi... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acid... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Servic... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services,... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pha... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Ph... Non Sterility; microbial contamination identified as Aspergillus species Class I 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.