Medicines, 2017
Shortlist up to four to read them side by side.
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 Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CLENZIderm M.D Discoloration. Class IIIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CLENZIderm M.D Discoloration. Class IIIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc.,… Subpotent Class IIIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedApr 26, 2017ClassClass IIIStatusTerminatedWhereNew York
- Medicine recall Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W.… Subpotent Class IIIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedApr 26, 2017ClassClass IIIStatusTerminatedWhereNew York
- Medicine recall Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print. Class IIIFDA’s classApr 19, 2017in FDA’s Enforcement ReportOhiothe one state its words name PublishedApr 19, 2017ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall Penicillin V Potassium Tablets, USP 500 mg Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg Class IIIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle Chemical Contamination Class IIIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Micronized Bulk cGMP Deviations; lack of quality assurance. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereColorado, Minnesota, New Jersey, New York, South Carolina and Texas
- Medicine recall Estradiol Non-Micronized, USP, Bulk cGMP Deviations; lack of quality assurance. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereColorado, Minnesota, New Jersey, New York, South Carolina and Texas
- Medicine recall Estriol Micronized, USP, Bulk cGMP Deviations; lack of quality assurance. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereColorado, Minnesota, New Jersey, New York, South Carolina and Texas
- Medicine recall Estrone Micronized, USP, Bulk cGMP Deviations; lack of quality assurance. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereColorado, Minnesota, New Jersey, New York, South Carolina and Texas
- Medicine recall Testosterone Micronized, Bulk cGMP Deviations; lack of quality assurance. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereColorado, Minnesota, New Jersey, New York, South Carolina and Texas
- Medicine recall Ethinyl Estradiol Micronized, USP, Bulk cGMP Deviations; lack of quality assurance. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereColorado, Minnesota, New Jersey, New York, South Carolina and Texas
- Medicine recall Levonorgestrel Non-Micronized, USP, Bulk cGMP Deviations; lack of quality assurance. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereColorado, Minnesota, New Jersey, New York, South Carolina and Texas
- Medicine recall LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Double Hyaluronic 1000, ‘AN OUNCE OF GOLD’ Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%,… Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100… cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC… cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5… cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid. Class IIIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid. Class IIIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid. Class IIIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Kalbitor (ecallantide), 10mg/mL Presence of Particulate Matter: Glass Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations Defective Delivery System: Elevated number of units with out of specification results for leak rate. Class IIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 12, 2017ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ciclopirox Olamine Cream USP, 0.77% Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ibuprofen Lysine Injection, 20 mg/2 mL Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For… Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
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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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