Medicines, 2013
Shortlist up to four to read them side by side.
1,376 medicine recalls FDA’s Enforcement Report published in 2013, 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.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only cGMP Deviation Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Lorazepam, 0.5 mg tablets, 100 count Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportIndianathe one state its words name PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereIndiana
- Medicine recall Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water) Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a)… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a)… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids) Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a)… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids) Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino… Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Voltaren 1% Gel, 100 gm tube Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be… Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass 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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