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 Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Althaea 6X, Iritable Bladder* 20% Alcohol, Drops Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cistus Canadensis 5X Coldness* 20% Alcohol drops Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quebracho 4C, Fever*, 20% Alcohol Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Viola od 6X, 30X, Bee Stings*, Sucrose/Lactose Pills, 6X Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Z-103 GU DETOXING Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Z-107 Formula Soft Tissue Healing Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZTE-1020 Formula Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Z-1020 Formula Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Z-1050 Formula Hepatodetox Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Z-1070 Formula Anxioheal Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZTE-1034 Formula Antimicrobial Bowel Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X,… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus… Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Strophanthus hisp 30X, Hives*, 20% Alcohol Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aconitum nap Fear* 20% Alcohol HPUS: 6X Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aconitum Napellus 12X Fear* 87% Alcohol HPUS Out-of-specification test results obtained for identification testing based on HPTLC analysis. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services,… Lack of sterility assurance. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereMassachusetts, Minnesota and New Hampshire
- Medicine recall ceFAZolin 3 G Lack of sterility assurance. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereMassachusetts, Minnesota and New Hampshire
- Medicine recall Sodium Phenylbutyrate Powder, 250 Grams Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial Lack of Assurance of Sterility Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Entacapone Tablets, USP, 200 mg Failed Dissolution Specifications Class IIFDA’s classSep 29, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereColorado, Florida, Missouri and Ohio
- Medicine recall Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons Failed Dissolution Specifications Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chantix (varenicline) tablets 0.5mg, 56 Tablets CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chantix (varenicline) tablets 1 mg, 56 Tablets CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sirolimus Tablets 1 mg, 30 Tablets Failed Impurities/Degradation Specifications Class IIIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5… CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Valproic Acid Oral Solution USP CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Sodium Sulfacetamide, 10%, Wash Subpotency: one product for active ingredient assay and another one for preservative assay Class IIIFDA’s classSep 29, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 29, 2021ClassClass IIIStatusTerminatedWhereOhio and Tennessee
- Medicine recall Hydroquinone, USP, 4% Skin Bleaching Cream Subpotency: one product for active ingredient assay and another one for preservative assay Class IIIFDA’s classSep 29, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 29, 2021ClassClass IIIStatusTerminatedWhereOhio and Tennessee
- Medicine recall X RATED HONEY FOR MEN Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IStatusCompletedWhereNationwide
- Medicine recall Fulvestrant Injection 250 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Naproxen Sodium Tablets, USP 275 mg 100 Tablets CGMP Deviations Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Naproxen Sodium Tablets, USP 550 mg CGMP Deviations Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chlorzoxazone Tablets USP 375 mg 100 Tablets CGMP Deviations Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chlorzoxazone Tablets USP 750 mg 100 Tablets CGMP Deviations Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zonisamide Capsules USP 50 mg 100 Capsules CGMP Deviations Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zonisamide Capsules USP 100 mg CGMP Deviations Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
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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