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 AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity. Class IIFDA’s classSep 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 12, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Living Well Remedies Weight Away Remedy, 2 fl oz Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Doxycycline Hyclate USP Tablets, 100 mg Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP 100 mL bags CGMP Deviations Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereMississippi and Texas
- Medicine recall Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain… Class IIIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets, USP 40 mg CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets, USP 80 mg CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets, USP 160 mg CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets, USP 320 mg CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP, 80mg, 90 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets USP, 160mg, 90 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets USP, 320mg, 90 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereSouth Carolina
- Medicine recall Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd Lack of assurance of sterility. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate injectable, 10%, 50 ml Single Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methyl-Cobalamin injectable, 1 mg/mL Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azelastine HCl Ophthalmic Solution 0.05%, 6 mL Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide Class IIIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ Labeling Error: Not elsewhere classified. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 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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