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 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles Cross Contamination with Other Products Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Children’s 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar… Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall children’s allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4… Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall children’s allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol… Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Euphoric Premium Male Performance Enhancer capsules Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 5% Dextrose Injection, USP Lack of Assurance of Sterility; bags have the potential to leak Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP Lack of Assurance of Sterility; bags have the potential to leak Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC… Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035,… Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Contrave (naltrexone HCl and bupropion HCl) Container packaging defect. Class IIIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 14, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L CGMP Deviations: Product was released to market prior to microbiological testing. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L CGMP Deviations: Product was released to market prior to microbiological testing. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots. Class IIIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 14, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12),… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12),… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12),… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12),… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12),… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12),… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30) Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12… Lack of Assurance of Sterility Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product… Microbial Contamination of Non-Sterile Product Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Native Remedies VertiFree Oral Spray, 2 fl oz Microbial Contamination of Non-Sterile Products FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Native Remedies HypoSlim Oral Spray, 2 fl oz Microbial Contamination of Non-Sterile Products FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Native Remedies VaricoGo Oral Spray, 2 fl oz Microbial Contamination of Non-Sterile Products FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Native Remedies EyeClear Pro Oral Spray, 2 fl oz Microbial Contamination of Non-Sterile Product FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Healthful Naturals DizziFree Oral Spray, 2 fl oz CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Man Power, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Brain Power,Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Woman Power, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MenoPower, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bone Builder, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AllergEase, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DigestivEase, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SleepEase, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 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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