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 5, 2026.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall ePHEDrine 50mg, 50 mg/10 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN 25,000 Units Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL) Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL) Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL.… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL) Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate, USP 50mg Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, USP, 250 mg, 0.9%… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 5 mcg Citrate, USP 5 mcg Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9%… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN 12,500 Units Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume:… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL) Volume: 30mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL) Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL) Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL) Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MORphine 150 mg (Morphine Sulfate, USP 150mg Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepiNEPHrine Bitartrate, USP 160 mcg Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume:… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate, USP 25 mg Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate, USP 50 mg Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for… Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Enalapril Maleate Tablets USP Failed Impurities/Degradation Specifications Class IIIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Enalapril Maleate Tablets USP Failed Impurities/Degradation Specifications Class IIIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Enalapril Maleate Tablets USP, 5 mg, 100 Tablets Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant Class IIIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 18, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Acetylcysteine for Injection 6 g/30 mL CGMP Deviations Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Monsel’s Solution (Ferric Subsulfate), 20% CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL)… Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle Subpotent Drug and Failed Content Uniformity. Class IIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle Subpotent Drug Class IIIFDA’s classJul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
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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