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 Phenol 6% Injectable, 30 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Methadone 10 mg/mL Injection, 10 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833 Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall CARBOplatin Injection 450 mg/45 mL Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time… Class IIIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 5 mg, 1000-count bottles CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril Tablets USP, 20 mg, 1000-count bottles CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle Failed Dissolution Testing: Failed 24 month dissolution testing. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle Lack of Assurance of Sterility: Failed preservative effectiveness testing. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. Class IIIFDA’s classAug 26, 2015in FDA’s Enforcement ReportOhiothe one state its words name PublishedAug 26, 2015ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SENSODYNE COMPLETE PROTECTION, 3.4 oz. Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01) Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle Failed Dissolution Specifications Class IIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation… Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky… Class IIFDA’s classAug 19, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 19, 2015ClassClass IIStatusTerminatedWhereTennessee and Texas
- Medicine recall Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL Incorrect Expiration Date: The “11/06” expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016) Class IIIFDA’s classAug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Methotrexate Injection, USP 50 mg/2 mL Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 19, 2015ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cytarabine Injection 100 mg/5 mL Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate… Failed Impurities/Degradation Specifications: out of specification for unknown impurity Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nisoldipine Extended Release Tablets, 17 mg Failed Dissolution Specifications Class IIIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class IIIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Mometasone Furoate Ointment USP, 0.1%, 15 g tubes Subpotent drug Class IIIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 12, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8 Failed Dissolution Specifications Class IIIFDA’s classAug 12, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 12, 2015ClassClass IIIStatusTerminatedWherePuerto Rico and US Virgin Islands
- Medicine recall Absorica (isotretinoin) Capsules, 25 mg Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall S-Methylcobalamin 1000 mcg/mL (PF) Injection Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall S-Chorionic Gonad HCG 1000 U/mL Injection Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall SIH-Testosterone Cyp. 200 mg/mL Injection Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall S-methylcobalamin 25 mg/mL (PF) Injection Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall SIH-Testosterone Cyp. 20 mg/mL Injection Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall SIU-Papaverine 30 mg/mL Inj. Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall SIU-Papav/Phent 24/1 mg/mL Inj. Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall SIU-Papav/Phentol 30/1 mg/mL Injection Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall SIU-Phent .4 mg/PGE1 20 mcg/mL Injection Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Class IIFDA’s classAug 12, 2015in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 12, 2015ClassClass IIStatusTerminatedWhereOklahoma
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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