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 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL Failed Impurities/Degradation Specifications; 12 month stability testing. Class IIIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC… Lack of Assurance of Sterility; due to leaking vials Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC… Lack of Assurance of Sterility; due to leaking vials Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall AIR COMPRESSED, Medical Air, USP Failed Impurities/Degradation Specification; out of specification results for carbon dioxide Class IIIFDA’s classApr 1, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 1, 2015ClassClass IIIStatusTerminatedWhereMichigan and Wisconsin
- Medicine recall B-Lipo, 30 Capsules Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container Lack of Assurance of Sterility. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container Lack of Assurance of Sterility. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX… Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereTexas
- Medicine recall DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin… Class IIIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicardipine Hydrochloride Injection, 25 mg/10 ml Subpotent Drug and Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ergoloid Mesylates ,1 mg tablets, 100 count bottle Failed Impurities/Degradation Specifications: during long-term stability testing. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Colistimethate for Injection USP, 150 mg per vial Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RIFAMPIN for Injection,USP, 600 mg per vial Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02) Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg,… Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point. Class IIFDA’s classMar 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin Tablets, USP, 20mg a) 90- count bottle Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class IIIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin Tablets, USP, 40mg Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class IIIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin Tablets, USP, 80mg Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class IIIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DICOPANOL (diphenhydramine hydrochloride Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml… Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product. Class IIFDA’s classMar 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles Failed Dissolution Specifications Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack Subpotent Drug Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32) Failed tablet specifications: One lot was found to contain oversized tablets. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atracurium Besylate Injection, USP, 50 mg per 5 mL Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially… Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atracurium Besylate Injection, USP, 100 mg per 10 mL Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially… Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg Labeling: Illegible label. Class IIIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedMar 11, 2015ClassClass IIIStatusTerminatedWhereNew Jersey
- Medicine recall Quinapril Tablets USP, 5 mg Subpotent Drug Class IIIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Quinapril Tablets USP, 40 mg Subpotent Drug Class IIIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g… Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack Subpotent Drug Class IIFDA’s classMar 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mafenide Acetate, USP, For 5% Topical Solution, STERILE Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution. Class IIFDA’s classMar 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 4, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medicine recall Ketorolac Tromethamine Inj., USP, 60 mg Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medicine recall Propofol Injectable Emulsion, 1%, 200 mg/20 mL Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 25, 2015ClassClass IStatusTerminatedWhereNationwide, and Michigan named
- Medicine recall Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class IIFDA’s classFeb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 25, 2015ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medicine recall 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall LACTATED RINGER’S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Erythromycin Pledgets USP, 2%, 60-count jar,Rx only Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam, extended release tablets, 750 mg, 60-count bottle Failed Dissolution Specifications: 6 month time point. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Compounded Plaquex, intravenous injection, 50 ML vial Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. Class IIFDA’s classFeb 18, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Children’s Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24… Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. Class IIFDA’s classFeb 11, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluconazole Injection, USP, 200 mg/100 mL Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Propofol Injectable Emulsion, 1%, 200 mg/20 mL Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. Class IIFDA’s classFeb 4, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 4, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Liposomal Amphotericin B 130 mg in dextrose bags Lack of sterility assurance. Class IIFDA’s classJan 28, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 28, 2015ClassClass IIStatusTerminatedWhereFlorida, Georgia, Louisiana, Mississippi, Texas and Virginia
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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