Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 9 Lyophilized Vial, For IM Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 9 A/B Lyophilized Vial, For IM Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 10 B Lyophilized Vial, For IM Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 7-Ketodehydroepiandrosterone Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 7-Keto DHEA 25mg Capsule Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine… Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets, USP, 160 mg, 90-count bottles Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Gabapentin Oral Solution, 250 mg/5 mL CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer. Class IIIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c)… Microbial Contamination of Non-Sterile Products Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when… Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int’l) Cop Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedJan 10, 2018ClassClass IStatusTerminatedWhereFlorida
- Medicine recall diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC… SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Class IIFDA’s classJan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL Labeling: Label MIX-UP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel… Class IIIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile Lack of Assurance of Sterility and cGMP Deviations Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets Failed Stability Specifications Class IIIFDA’s classJan 3, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 3, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Fentanyl 10 mcg Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Fentanyl 2 mcg/mL and ropivacaine 0.2% Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall HYDROmorphone 10 mg Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Morphine 50 mg Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Oxytocin 30 units Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Phenylephrine 1000 mcg Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Succinylcholine chloride 100 mg Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. Class IIFDA’s classJan 3, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedJan 3, 2018ClassClass IIStatusTerminatedWhereMissouri
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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