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 Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags Lack of Assurance of Sterility: Sterility of product is not assured. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportArkansasthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag Lack of Assurance of Sterility: Sterility of product is not assured. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportArkansasthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags Lack of Assurance of Sterility: Sterility of product is not assured. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportArkansasthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag Lack of Assurance of Sterility: Sterility of product is not assured. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportArkansasthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag Lack of Assurance of Sterility: Sterility of product is not assured. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportArkansasthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags Lack of Assurance of Sterility: Sterility of product is not assured. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportArkansasthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes Lack of Assurance of Sterility: Sterility of product is not assured. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportArkansasthe one state its words name PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Disulfiram tablets, USP, 500 mg, 100-count bottles Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for… Class IIIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall E-Z-CAT Dry Barium Sulfate for Suspension Failed stability specifications:This recall has been initiated due to out of specification results for viscosity. Class IIIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers… Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts. Class IIIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dr Blue Pain Relieving Gel Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol. Class IIIFDA’s classJul 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Famotidine Tablets, USP, 20 mg Tablets, Over the Counter CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints. Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC… Failed Dissolution Specifications; exceeded specification at the 9 hour time point Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles Failed Dissolution Specifications; exceeded specification at the 9 hour time point Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of… Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNew Jersey
- Medicine recall Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of… Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNew Jersey
- Medicine recall Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters Failed dissolution specifications Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60… Class IIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally… Superpotent Drug: Out Of Specification (OOS) result for Assay. Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg Subpotent drug Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg Subpotent drug Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle Subpotent drug Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg Subpotent drug Class IIIFDA’s classJun 24, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Bimix (PHENT;PAP) (N), solution Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Trimix (PGE1;PHENT;PAP) (N), injectable Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Trimix (PGE1;PHENT;PAP) (N), injectable Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class IIFDA’s classJun 17, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereMontana and North Dakota
- Medicine recall Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz Failed Impurities/Degradation Specifications Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz Failed Impurities/Degradation Specifications Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container Subpotent Drug; out of specification results for heparin raw material Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP) Labeling: incorrect or missing lot number and/or expiration date Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall PHENYLephrine HCl 50 mg Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose. Class IIFDA’s classJun 17, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 17, 2015ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle Failed Dissolution Specifications: Low out of specification dissolution results. Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle Failed Dissolution Specifications: OOS result during stability testing Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets… Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall KABIVEN [(3.9%) Lipid Injectable Emulsion with Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids Class IIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point. Class IIIFDA’s classJun 10, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2015ClassClass IIIStatusTerminatedWhereNationwide
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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