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 Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium. Class IIFDA’s classJan 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled Labeling: Label Error on Declared Strength. Class IIIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gabapentin Tablets, USP, 800 mg, 500-count Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereOhio
- Medicine recall Ephedrine sulfate 5 mg/mL Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereIowa and Wisconsin
- Medicine recall Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereIowa and Wisconsin
- Medicine recall Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereIowa and Wisconsin
- Medicine recall Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereIowa and Wisconsin
- Medicine recall Anastrozole 0.5 mg Capsules Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Anastrozole SR 1 mg Capsules Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Est (Estriol/Estradiol) Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estriol 0.1% Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT) Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Liothyronine SR (T3) 20 mcg Capsule Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylene Blue (PF) 10 mg/mL Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nicotinamide Adenine Dinucleotide 500 mg Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin 30 Units Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PrednisoLONE 10 mg Tablet Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Progesterone 3% Topical Cream Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QUADMIX #16, 5 mL Vial Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QUADMIX #17, 5 mL Vial Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QUADMIX #18, 5 mL Vial Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin 500 mcg Orally Disintegrating Tablets (ODT) Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sincalide 5 mcg Lyophilized Vials, For IV Use Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. Class IIFDA’s classJan 17, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 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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