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 VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add… Defective Container: Confirmed reports of loose vial crimps. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Transdermal System. 25 mcg/h Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Class IIIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Transdermal System, 50 mcg/h Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Class IIIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Transdermal System. 75 mcg/h Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Class IIIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Transdermal System, 100 mcg/h Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Class IIIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Labeling: Label Error on Declared Strength Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aripiprazole Tablets, USP, 10 mg, 30-count bottles CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule Failed Stability Specifications Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case… Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date. Class IIIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BLUE PEARL capsules, 500mg, 1-count packets Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol Class IIIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Cream USP, 0.05% 60 g tube Failed Content Uniformity Specifications Class IIIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265… Labeling: Label Error on Declared Strength Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10% Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Vaginal Delivery CDS Pack, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Vitrectomy CDS Pack, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline RAD NECK ENT TRAY Pack, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Newborn Kit Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Concordia Trunk Kit Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Concordia Nurse Bag Kit Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Pediatric IV Kit Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline CNTRL Line Removal Kit Scripps Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Trunk Kit, Non-sterile Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline TRAY, CATHETER CARE, LIDDED Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Suture Removal Tray Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline IV Start Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Central Line Dressing Change Tray Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Incision and Drainage Tray Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline I&D Tray Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Sheath Removal Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Wound Closure Tray, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline General Purpose Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline DC Line Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Dressing Change Tray Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Circumcision Tray Kit, Sterile, Single use only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Catheter Insertion Kit, Sterile Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline All Purpose Instrument Tray, Sterile Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline General Purpose Tray, Sterile, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Laceration Tray, Sterile, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Suture Removal Tray, Sterile, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline GHS Suture Removal Tray, Sterile, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline Staple Remover Tray, Sterile, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Medline General Purpose Tray, Sterile, Single Use Only Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Class IIFDA’s classFeb 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
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.