Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall Indomethacin Capsules, USP, 50 mg, 100-count bottles Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Valsartan tablets 160 mg, 90-count bottle Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Daptomycin for Injection, 500 mg per vial Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological… Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle Failed Dissolution Specifications: Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle Failed Dissolution Specifications: Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxycycline Hyclate Tablets, USP, 100 mg Failed Dissolution Specifications Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereFlorida, Hawaii and Indiana
- Medicine recall Valsartan 320 mg tablets, 30-count bottles ( CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereFlorida, Hawaii and Indiana
- Medicine recall Valsartan 320 mg tablets, 90-count bottles ( CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereFlorida, Hawaii and Indiana
- Medicine recall Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor. Class IIIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 8, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg Failed Stability Specifications: lot out of specification for elevated water vapor. Class IIIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 8, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. Class IIIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 8, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study. Class IIIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Unit Dose Valsartan Tablets, USP, 80 mg CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Unit Dose Valsartan Tablets, USP. 160 mg CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Testosterone Cypionate Injection, USP, 200 mg/mL Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to… Class IIIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 1, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to… Class IIIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 1, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19) CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10) CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10) CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05) CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 1, 2018ClassClass IIStatusOngoingWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Enalapril Maleate, USP 2.5MG, 90-count bottle Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. Class IIIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Enalapril Maleate, USP 5MG, 90-count bottle Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. Class IIIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Enalapril Maleate, USP 5MG, 30-count bottle Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. Class IIIFDA’s classAug 1, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g Incorrect Product Formulation: wrong sunscreen product in the package. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water) Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Metformin Hydrochloride Extended Release Tablets, USP, 500 mg Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a… Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportArizonathe one state its words name PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereArizona
- Medicine recall 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose… Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ceFAZolin 2 gm in NS 100mL Lack of Assurance of Sterility: Potential leakage of bags. Class IIFDA’s classJul 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2018ClassClass 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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