Medicines, 2020
Shortlist up to four to read them side by side.
1,035 medicine recalls FDA’s Enforcement Report published in 2020, 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.
1,035of 1,035 medicine recallsshown with your filters
The list
- Medicine recall Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles CGMP Deviations Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Subpotent drug. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL Subpotent Drug: Low out-of-specification assay results for the epinephrine component. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities. Class IIFDA’s classDec 30, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 30, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Indiana, Kentucky, Ohio and Texas
- Medicine recall Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets Failed Dissolution Specifications Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets Failed Dissolution Specifications Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use Subpotency: Out-of-specification stability test result for low potency was obtained. Class IIIFDA’s classDec 23, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 23, 2020ClassClass IIIStatusTerminatedWhereLouisiana and Missouri
- Medicine recall Vumerity (diroximel fumarate) delayed-release capsule, 231 mg Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized Cross contamination: the excipient was found to be contaminated with theophylline. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusCompletedWhereNationwide
- Medicine recall CVS Health Athlete’s Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Equate Athlete’s Foot, Clotrimazole USP 1%, Antifungal Cream Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall H-E-B - Athlete’s Foot Cream Clotrimazole Cream USP, 1% Anitfungal Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kroger Athlete’s Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Best Choice, Clotrimazole Cream, USP 1%, Antifungal Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TopCare Health, Athlete’s Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Athlete’s Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic Subpotent drug Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Nevada and Texas
- Medicine recall CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ Subpotent drug Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Nevada and Texas
- Medicine recall Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ Subpotent drug Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Nevada and Texas
- Medicine recall UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ Subpotent drug Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Nevada and Texas
- Medicine recall Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ Subpotent drug Class IIFDA’s classDec 23, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Nevada and Texas
- Medicine recall Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial cGMP deviations: Vials may not be sealed correctly affecting sterility. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sildenafil Tablets USP 100 mg Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TraZODONE Hydrochloride Tablets USP 100 mg Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall V-Klean Hand Sanitizer Gel Alcohol 70% Lack of CGMPs: Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ Lack of CGMPs: Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Dexmedetomidine HCl Cross Contamination with other products: trace amounts of lidocaine FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass 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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