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 5, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr… Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA… Class IIIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684 Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684 Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydroxocobalamin MDV 5 mg/mL Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportConnecticutthe one state its words name PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereConnecticut
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had… Class IIIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070. Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereOregon and Washington
- Medicine recall Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy,… Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding… Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800. Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800. Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park… Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereCalifornia and Indiana
- Medicine recall Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For… Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereCalifornia and Indiana
- Medicine recall Testosterone Cypionate (Sesame Oil) 200mg/mL for injection Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereCalifornia and Indiana
- Medicine recall Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ. Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869 Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of… Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 The product lots are being recalled due to laboratory results indicating microbial contamination. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall K EFFERVESCENT TABLETS, 25 meq POTASSIUM LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNo state named
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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