Medicines, 2015
Shortlist up to four to read them side by side.
2,020 medicine recalls FDA’s Enforcement Report published in 2015, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a… Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq… Class IIIFDA’s classApr 22, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedApr 22, 2015ClassClass IIIStatusTerminatedWhereOklahoma
- Medicine recall Fomepizole Injection, 1.5 g/1.5 mL Lack of Assurance of Sterility. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San… Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy,… Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine. Class IIIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall KETOROLAC Tromethamine Inj., USP, 30 mg Crystallization Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall KETOROLAC Tromethamine Inj., USP, 60 mg Crystallization Class IIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle Crystallization Class IIFDA’s classApr 15, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 15, 2015ClassClass IIStatusTerminatedWhereOklahoma and Pennsylvania
- Medicine recall University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%,… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Children’s Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%,… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml,… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq,… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g, compound vol: 100 ml, sterile… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, compound vol:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, compound vol:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml,… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 5%, Additives: heparin… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%, compound vol: 250… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%,… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol:… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium… Non-Sterility: Out of specification results for the sterility test for microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2015ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride… Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature… Class IIIFDA’s classApr 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clinimix E 5/20 sulfite-free Lack of Assurance of Sterility; increased complaints received for leaks Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack Lack of Assurance of Sterility; increased complaints received for leaks Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benzonatate Capsules, USP, 100 mg, 100 count Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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