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 6, 2026.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNew Jersey and New York
- Medicine recall Tiger King tablets, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction,… Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml Lack Of Assurance Of Sterility Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. Class IIIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medicine recall Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medicine recall Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medicine recall Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medicine recall Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medicine recall Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medicine recall Earth’s Care Eczema Lotion Microbial Contamination of Non-Sterile Products. Class IIFDA’s classJan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hard Times For Men capsules Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 31, 2018ClassClass IStatusTerminatedWhereNo state named
- Medicine recall BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481 Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 31, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) Subpotent FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 31, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 31, 2018ClassClass IStatusTerminatedWhereTexas
- Medicine recall bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%,… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on… Class IIIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate Subpotent Drug Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL 100 mcg per mL Superpotent Drug Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lovastatin Tablets USP, 40 mg, 50 Tablets Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin Tablets, USP, 40 mg, 1000-count bottle Presence of foreign substance: metallic razor blade was found in one bottle. Class IIIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint Microbial Contamination of Non Sterile Product; presence of yeast and potential B. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereMichigan
- Medicine recall Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint Microbial Contamination of Non Sterile Product; presence of yeast and potential B. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereMichigan
- Medicine recall Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz Microbial Contamination of Non Sterile Product; presence of yeast and potential B. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereMichigan
- Medicine recall Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl Microbial Contamination of Non Sterile Product; presence of yeast and potential B. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereMichigan
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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