Medicines, 2014
Shortlist up to four to read them side by side.
1,562 medicine recalls FDA’s Enforcement Report published in 2014, 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 5, 2026.
1,562of 1,562 medicine recallsshown with your filters
The list
- Medicine recall G.A.C. 375 Injection USP Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall L-Carnitine Injection USP 100 mg/ml Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutathione Injection USP, 200 mg/ml Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets Failed Dissolution Specification; at the 12 month time interval. Class IIIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. Class IIIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 6, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial Failed Stability Specifications: Out of specification result for preservative sodium benzoate. Class IIIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Post Procedure Cream, 1 ounce containers which were Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Calm & Correct Cream Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Baby’s Relief Calm and Repair Cream Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Complexion Repair Topical Rehydrating Emulsion which was Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Calm and Correct Serum, 2 oz Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Post Procedure Cream 1 oz Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Calm and Correct Cream 2 oz Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dermamedics Complexion Repair Topical Rehydrating Emulsion Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Therametics Complexion Repair Topical Rehydrating Emulsion Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fagron, Phytobase Cream, 500 g, Article number: 802156 Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fagron, Pentravan Base 2.5 Kg, Article number: 802486 Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749 Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP… Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for… Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP, 0.25mg Presence of Foreign Substance; tablets may contain stainless steel metal particulates Class IIFDA’s classAug 6, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine HCl Injection, 1000 mcg/10 mL Labeling: Label Error On Declared Strength: The side label description incorrectly states “Each mL contains 500 mcg Clonidine Hydrochloride” instead of stating… Class IIIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count… Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. Class IIIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 30, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 30, 2014ClassClass IStatusTerminatedWhereColorado, Massachusetts, Ohio, Texas and Wyoming
- Medicine recall Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 30, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 30, 2014ClassClass IStatusTerminatedWhereColorado, Massachusetts, Ohio, Texas and Wyoming
- Medicine recall metFORMIN ER Tablets, 500 mg, Rx Labeling: Label Mix up; product labeled did not indicated Extended Release FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 30, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 30, 2014ClassClass IStatusTerminatedWhereColorado, Massachusetts, Ohio, Texas and Wyoming
- Medicine recall Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereColorado, Massachusetts, Ohio, Texas and Wyoming
- Medicine recall Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim… Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereColorado, Massachusetts, Ohio, Texas and Wyoming
- Medicine recall Docusate Calcium Softgel Capsules, 240 mg, OTC Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg Class IIFDA’s classJul 30, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 30, 2014ClassClass IIStatusTerminatedWhereColorado, Massachusetts, Ohio, Texas and Wyoming
- Medicine recall DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL… Stability Data Does Not Support Expiry Class IIIFDA’s classJul 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx #… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJul 30, 2014in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 30, 2014ClassClass IIStatusOngoingWhereFlorida
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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