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 SIU-Papav/Phent 30/1 mg 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/.5 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 .8/PGE1 20 mcg/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-Prostaglandin E1 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
- Medicine recall SIU-Tri-Mix 17/0.6/5.7 Injectable 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-Tri-Mix 18/1/20 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-Tri-Mix 6/0.33/3.33 Injection Solution 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-Tri-Mix 18/1/10 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-Tri-Mix 20/1 mg/10 mcg/mL 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-Tri-Mix 24/1/20 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-Tri-Mix 30/1/10 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-Tri-Mix 30/2/20 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-Tri-Mix 24 mg/1 mg/10 mcg/mL 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-Tri-Mix 30/1/20 Injectable 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 SO-Acetylcysteine 10% Sterile Ophthalmic Solution 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-Prostaglandin E1 500 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
- Medicine recall SIU-Phentolamine 5 mg/mL in Normal Saline 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-Hydroxyprogesterone Caproate 250 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 5000 mcg/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 COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4… Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clonidine Hydrochloride Tablets, USP, 0.1 mg cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Clonidine Hydrochloride Tablets, USP, 0.2 mg cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Amlodipine Besylate Tablets, 2.5 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 2.5 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zolpidem Tartrate Tablets, 5 mg Tablets, CIV CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Azithromycin Tablets, USP, 250 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Famotodine Tablets, USP, 40 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zonisamide Capsules, 100 mg Capsules CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate Tablets, 5 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate Tablets, 10 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count… CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 10 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 20 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 30 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 40 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zolpidem Tartrate Tablets, 10 mg Tablets, CIV CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Azithromycin Tablets, USP, 500 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Azithromycin Tablets, USP, 600 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Famotodine Tablets, USP, 20 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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