Medicines, 2018
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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 Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Class IIIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle Subpotency: lower than expected potency result was obtained at the 18 month stability time point. 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, 30-count bottle Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Class IIIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP, 80 mg, 90-count bottle Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Class IIIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP, 160 mg, 90-count bottle Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Class IIIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP, 320 mg, 90-count bottle Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Class IIIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportAlabamathe one state its words name PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereAlabama
- Medicine recall Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1) CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1) CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per… Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer Class IIIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Camber Pharmaceuticals, Inc CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Camber Pharmaceuticals, Inc CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Camber Pharmaceuticals, Inc CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Camber Pharmaceuticals, Inc CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Acne Treatment Pads Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label. Class IIIFDA’s classAug 22, 2018in FDA’s Enforcement ReportVirginiathe one state its words name PublishedAug 22, 2018ClassClass IIIStatusTerminatedWhereVirginia
- Medicine recall Lisinopril Tablets USP, 10mg, 1000-count bottles Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube Microbial Contamination of a Non-Sterile Product Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Atorvastatin Calcium tablets, 40 mg, 500-count bottle Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability… Class IIIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atropine 0.01% Opth Solution, 5 mL droptainer Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall DMSO 6.25% Opth Sol, 10 mL droptainer Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Avastin 1.25 mg/0.05 mL prefilled syringe Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Morphine Sulf inhalation, 5mg/3cc, 3cc per vial Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Dehydrated Alcohol Solution Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Acetylcysteine 10% Oph Solution, 10 mL droptainer Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Valsartan, 160 mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportIndianathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportIndianathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall Valsartan, 80mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportIndianathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall Valsartan, 320mg, 30 tablets per bottle CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement ReportIndianathe one state its words name PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle Defective Container: Customer complaints of punctures in the bottle. Class IIIFDA’s classAug 22, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereFlorida and Virginia
- Medicine recall Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereFlorida and Virginia
- Medicine recall Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class IIFDA’s classAug 22, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 22, 2018ClassClass IIStatusTerminatedWhereFlorida and Virginia
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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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