Medicines, 2022
Shortlist up to four to read them side by side.
1,349 medicine recalls FDA’s Enforcement Report published in 2022, 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.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall SEMAGLUTIDE INJECTION 5MG/ML Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall TALC, STERILE POWDER, 5 GM vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family… Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe,… Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL cGMP Deviations: Out of specification for assay of one of the preservative ingredients. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atenolol Tablets, USP, 25 mg, 1000-count bottle Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe Subpotent Drug: Out of specification for assay Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class IIFDA’s classNov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles Out of specification for related substances (impurities). Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Rifampin Capsules, USP, 300 mg Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rifampin Capsules, USP, 150 mg, 30-count bottle Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acyclovir Sodium Injection, 500mg/10mL Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/… Boxes mislabeled to read “Decongestant Free”, but the product contains Phenylephrine HCI 5mg Class IIIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR… Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Skincell Mole & Skin Corrector Serum, 1 fl Marketed Without An Approved NDA/ANDA; Unapproved new drug Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 19, 2022ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Skincell Mole & Skin Corrector Serum, 1 fl Marketed Without An Approved NDA/ANDA; Unapproved new drug Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 19, 2022ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Sanitizing Hand Spray 80% (alcohol 80% v/v) GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 12, 2022ClassClass IIStatusTerminatedWhereFlorida and Washington
- Medicine recall Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) Chemical Contamination: product found to contain benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 12, 2022ClassClass IStatusTerminatedWhereFlorida and Washington
- Medicine recall Aminophylline Injection, USP 250 mg/10 mL Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 12, 2022ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. Class IIIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 12, 2022ClassClass IIIStatusTerminatedWhereNorth Carolina
- Medicine recall Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. Class IIIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIIStatusCompletedWhereNationwide
- Medicine recall Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial Lack of Assurance of Sterility: environmental monitoring failure. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tranexamic Acid Injection, USP, 1000mg per 10 mL Presence of Particulate Matter: Piece of metal found in a vial Class IIIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg Superpotent Drug: Out of specification for assay at the 12-month timepoint. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg Superpotent Drug: Out of specification for assay at the 12-month timepoint. Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP, 2 grams/vial Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 5, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall oxyTOCIN 30 Units/500 mL Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL). Class IIIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 5, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
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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