Medicines, 2017
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1,073 medicine recalls FDA’s Enforcement Report published in 2017, 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.
1,073of 1,073 medicine recallsshown with your filters
The list
- Medicine recall Activase (alteplase), 100 mg Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as… Class IIIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine… CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg… CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Paroxetine tablets USP, 30mg, 30-count bottles Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL… Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance Class IIIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl Microbial contamination of Non-sterile Products; potential B. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16… Microbial contamination of Non-sterile Products; potential B. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ANDROPHARM STEN Z Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2017in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 20, 2017ClassClass IStatusTerminatedWhereFlorida
- Medicine recall ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2017in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 20, 2017ClassClass IStatusTerminatedWhereFlorida
- Medicine recall New Kopi Jantan Tradisional Natural Herbs Coffee Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 20, 2017ClassClass IStatusTerminatedWhereNationwide, and Texas named
- Medicine recall Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247) Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PF-Glutathione 200mg/ml, 30 mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 10mg Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mannitol 20%, 10 mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall G.A.C 25/100/250mg, 30 mL Vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium chloride 10%, 10 mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-Complex, 30 mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 10mg Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Magnesium Chloride 200mg, 30m L vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall L-Glutamine 100mg, 30 mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIC 25/50/50, 30mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Ophthalmic Gel 3.5%, 15mL bottles Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate 8.4%, 10 mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluorescein Sodium, 5mL vials Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BevaDex (bevacizumab) 0.06mL Prefilled 32 g Lack of Assurance of Sterility. Class IIFDA’s classSep 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine, USP Capsules, 15 mg, 30 count bottles Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample… Class IIIFDA’s classSep 20, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 20, 2017ClassClass IIIStatusTerminatedWhereCalifornia and Nevada
- Medicine recall Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle CGMP Deviations Class IIIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Propafenone Hydrochloride tablets, 150 mg Failed moisture limits: Out of specification for moisture content. Class IIIFDA’s classSep 13, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 13, 2017ClassClass IIIStatusTerminatedWhereColorado, Illinois, Louisiana, Ohio and Pennsylvania
- Medicine recall Povidone Iodine, USP Prep Solution, 10% Labeling: Label mix-up. Class IIFDA’s classSep 13, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereCalifornia and Illinois
- Medicine recall Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded… Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed… Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Timolol-Latanoprost PF Solution Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Timolol-Brimonidine-Dorzolamide-Latanoprost Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier Class IIFDA’s classSep 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Tromethamine Injection, USP 30 mg/mL Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when… Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Morphine Sulfate Oral Solution, 100 mg/ 5 mL Defective container: Oral solution leaking from container. Class IIFDA’s classSep 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenobarbital Tablets USP, 15 mg, 1000 count bottles Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Phenobarbital Tablets USP, 30 mg, 1000 count bottles Labeling: Label Mixup; potentially mislabeled FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Phenobarbital Tablets USP, 60 mg, 1000 count bottles Labeling: Label Mixup; potentially mislabeled Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC… Labeling: Label Mixup; potentially mislabeled Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles Labeling: Label Mixup; potentially mislabeled Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenobarbital Tablets USP, 15 mg, 1000 count bottles Labeling: Label Mixup; potentially mislabeled Class IIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 30, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 30, 2017ClassClass IStatusTerminatedWhereTexas
- Medicine recall Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample… Class IIIFDA’s classAug 30, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2017ClassClass 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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