Medicines, 2019
Shortlist up to four to read them side by side.
2,152 medicine recalls FDA’s Enforcement Report published in 2019, 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 7, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall curaplex Epi Safe Administration and Training Kits # 8600-01100 Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Curaplex Epi Safe Kit Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. Class IIIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed) CGMP Deviation; manufacturing batch record could not be located Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg Failed dissolution specifications Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Vaginal Inserts, USP, 10 mcg Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dianeal Low Calcium Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cidofovir Injection 375mg/5mL Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ceftriaxone for Injection USP, 250 mg Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 16, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ceftriaxone for Injection USP, 500 mg Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 16, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ceftriaxone for Injection USP, 1 g Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 16, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ceftriaxone for Injection USP, 2 g Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 16, 2019ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Buffered Lidocaine HCl (buffered Subpotent Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefdinir for Oral Suspension USP, 125mg/5mL CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefdinir for Oral Suspension USP, 250mg/5mL CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton GMP Deviations: A silicone particulate was noted in Ozurdex. Class IIFDA’s classJan 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2019ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Epinephrine liquid 1:1000, RX, glass vial Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Glutathione liquid, 100mg/ml Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall HCG liquid, 1000u/ml, RX, glass vial, various Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Lidocaine gel 2%, RX, plastic dropper Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile… Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Methocarbamol liquid 100mg/ml, RX, glass vial Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Testosteron Cypionate liquid 200mg/ml, RX, glass vial Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Vitamin B12 liquid 1000mcg/ml, RX, glass vial Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Cyclosporin liquid 1%, Rx, plastic dropper bottle Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Cyclosporin liquid 0.5%, Rx, plastic dropper bottle Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Cyclosporin liquid 0.2%, Rx, plastic dropper bottle Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Cyclosporin liquid 0.05%, Rx, plastic dropper bottle Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Glutathione liquid, 200mg/ml, Rx Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Lidocaine gel 1%, RX, plastic dropper Lack of sterility assurance. Class IIFDA’s classJan 9, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedJan 9, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Temozolomide Capsules, 20 mg Failed Dissolution Specifications Class IIIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 2, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Temozolomide Capsules, 180 mg Failed Dissolution Specifications Class IIIFDA’s classJan 2, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 2, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly… Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as “10 mcg per mL” rather than the correct concentration of “100 mcg per mL”. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 2, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 2, 2019ClassClass IStatusTerminatedWhereNew Mexico, Ohio and Texas
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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