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 ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Artesunate for Injection, 110 mg/vial Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle… Product Mix-up: Incorrect diluent component included in the kit. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point. Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Meclizine HCl Tablets, 25 mg Labeling: Incorrect Instructions Class IIFDA’s classOct 13, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 13, 2021ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Ruzurgi (amifampridine) Tablets 10 mg Microbial contamination of non-sterile products: Firm’s testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 6, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 6, 2021ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate… cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone Chemical Contamination: presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone Chemical Contamination: presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone cGMP Deviations Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles Failed Dissolution Specifications Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ Subpotent Drug Class IIIFDA’s classOct 6, 2021in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 6, 2021ClassClass IIIStatusTerminatedWhereAlabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia
- Medicine recall CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL… Subpotent Drug Class IIIFDA’s classOct 6, 2021in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 6, 2021ClassClass IIIStatusTerminatedWhereAlabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia
- Medicine recall Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroquinone USP, 4% Skin Bleaching Cream Finished product specification did not meet USP specifications. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportTennesseethe one state its words name PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial Defective container: Cracked vials leading to lack of sterility assurance 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* 87% Alcohol HPUS: 5X, 7X, 18X, 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 ZTE-105 Formula Gentle 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 Occular Allergy Blend 87% 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 Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic… 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 Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 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 Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder allerges 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 Officinalis 4X, Iritable Bladder* 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 Cinnamomum 6X, Flatulence* 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 6X, 10X, 15X, 30X, Coldness* 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 Humulus 6X, 15X, 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 Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C 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 Verbena Officinalis 6X, Nervousness* 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 Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X 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 La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter… 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 Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Use Only 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 Officinalis 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
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.
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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