Medicines, 2021
Shortlist up to four to read them side by side.
1,016 medicine recalls FDA’s Enforcement Report published in 2021, 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.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE Lack of assurance of sterility Class IIFDA’s classNov 17, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medicine recall TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE Lack of assurance of sterility Class IIFDA’s classNov 17, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medicine recall TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 10 INJ INJECTABLE Lack of assurance of sterility Class IIFDA’s classNov 17, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medicine recall TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE Lack of assurance of sterility Class IIFDA’s classNov 17, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medicine recall Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some… Class IIFDA’s classNov 17, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereArizona and Missouri
- Medicine recall Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity Class IIFDA’s classNov 17, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereArizona and Missouri
- Medicine recall Cefixime Capsules 400 mg, 50 capsules bottles Failed Impurities/Degradation Specifications Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tadalafil Tablets, USP 5 mg, 30 count bottle Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tadalafil Tablets, USP 20 mg, 30 count bottle Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. Class IIFDA’s classNov 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddy’s Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddy’s Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddy’s Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddy’s Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC… Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddy’s Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr.… Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some… Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count… CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count… CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class IIFDA’s classNov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methocarbamol 500mg Tablet Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IStatusCompletedWhereNationwide
- Medicine recall Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial Presence of Particulate Matter: Identified as Glass Particles FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 10, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Calcium Chloride, 100 mg/mL MDV INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall Magnesium Chloride, 200 mg/mL MDV INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall LEVOCARNITINE 100MG/ML MDV SOLN Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF) Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall CYCLOSPORIN 0.2% OIL OPTH SUSP Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall CYCLOSPORINE 2% MCT OIL SUSP Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall DEXPANTHENOL 250MG/ML INJ SOLN Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall ESTRADIOL VALERATE 5MG/ML MDV INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall GLUTATHIONE 200MG/ML MDV Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall HYDROXYPROG CAPROATE 250MG/ML OIL INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall LEVOCARNITINE 100MG/ML MDV SOLN Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP 100MG/ML IN ETHYL OLEATE OIL Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP 200MG/ML IN SESAME OIL MDV Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP 200MG/ML MDV ETHYL OLEATE Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP 25MG/ML IN ETHYL OLEATE MDV Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP 50MG/ML IN ETHYL OLEATE OIL Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP/PROP/DECA-NAN 125MG/ML Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TEST CYP/PROP/DECA-NAN 125MG/ML Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall VIT B COMPLEX INJ SOLN (HP) Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall VIT B COMPLEX INJ SOLN (HP) Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall ACETYLCYSTEINE 2% OPTH SOLN Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
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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