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 5, 2026.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine… Subpotent Drug: trace amounts of methylcobalamin in compounded drug. Class IIFDA’s classOct 7, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereAlabama and Tennessee
- Medicine recall All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550 Lack of Assurance of Sterility Class IIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 7, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits. Class IIIFDA’s classOct 7, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 7, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use… Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate, 1 mg per mL Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate, 5 mcg per mL Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Ketamine Hydrochloride Injection, USP Defective Container: There were customer complaints of cracked and leaking glass vials. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02 Subpotent Drug: Low out-of-specification potency result of the drug product. Class IIIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dexmethylphenidate HCl Extended-Release, Capsules, 10mg Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point… Class IIIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedSep 23, 2015ClassClass IIIStatusTerminatedWhereNew Jersey
- Medicine recall 5-Methyl Tetrahydrofolate Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 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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