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 Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could… Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No.… CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing. Class IIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states “Two to four tablets four times daily.” rather than… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable… Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable… Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Class IIIFDA’s classOct 10, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Montelukast Sodium Tablets 10 mg, 30-count bottle Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IStatusOngoingWhereNationwide
- Medicine recall Zoledronic Acid Injection, 5mg/100 mL Failed Impurities/Degradation Specifications: OOS for unknown impurities. Class IIIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zoledronic Acid Injection, 5 mg/100 mL Failed Impurities/Degradation Specifications: OOS for unknown impurities. Class IIIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fenofibrate Tablets, USP 145 mg, 90-count bottles Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg. Class IIIFDA’s classOct 3, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 3, 2018ClassClass IIIStatusTerminatedWhereIndiana and Louisiana
- Medicine recall Montelukast Sodium Tablets, 10 mg*, 30-count bottles Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Injection Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Class IIIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 3, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg Cross Contamination With Other Products: Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine 4 mg Subpotent Drug: Product may not have the active ingredient present in the bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 cGMP Deviation Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tizanidine HCl Tablets, USP 2mg, 150-count bottles Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Skin Irritation & Itch Response Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sinus Response Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diarrhea Response Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Muscle & Joint Pain Relief Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy & Hay Fever Relief Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Colds & Flu Response Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Arthritis Pain Relief Homeopathic Formula, 2 FL CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay. Class IIIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bupropion Hydrochloride ER Tablets, USP 150 mg Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older… Class IIIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for… Class IIIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Argatroban Injection, 250 mg/2.5 mL Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point Class IIIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole dihydrochloride extended release tablets, 0.75 mg Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels. Class IIIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. Class IIIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. Class IIIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution Defective Delivery System: Water ingress through the lower water cup sensor of the device. Class IIIFDA’s classSep 19, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 19, 2018ClassClass IIIStatusTerminatedWhereIllinois and Pennsylvania
- Medicine recall Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 19, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 19, 2018ClassClass IStatusTerminatedWhereConnecticut, District of Columbia and Virginia
- Medicine recall Compulsin, Homeopathic (OTC Medicine), 2 fl oz Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2018ClassClass IStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Neuroveen, Homeopathic (OTC Medicine), 2 fl oz Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2018ClassClass IStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Thyroveev, Homeopathic (OTC Medicine), 2 fl oz Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2018ClassClass IStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Respitrol, Homeopathic (OTC Medicine), 2 fl oz Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2018ClassClass IStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 19, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL Supterpotent Drug 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 80 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 160 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
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.”
Your shortlist0 of 4
Add one more to compare.