Medicines, 2017
Shortlist up to four to read them side by side.
1,073 medicine recalls FDA’s Enforcement Report published in 2017, 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.
1,073of 1,073 medicine recallsshown with your filters
The list
- Medicine recall MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by… Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROCAINE HCL SDV 1% INJ, Injection, 1% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROCAINE HCL SDV 2% INJ, Injection, 2% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM BICARB 50ML MDV 8.4% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90% Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Desoximetasone Ointment USP, 0.25%, 15 g tubes Superpotent Drug Class IIIFDA’s classMay 24, 2017in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMay 24, 2017ClassClass IIIStatusTerminatedWhereTennessee
- Medicine recall Fluconazole Injection, USP, 200 mg/100 mL Lack of assurance of sterility: customer complaints received for the presence of leaks. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Milrinone Lactate Lack of assurance of sterility: customer complaints received for the presence of leaks. Class IIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Fluocinonide Cream UPS, 0.05% (Emulsified Base) Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate. Class IIIFDA’s classMay 24, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall IC-Green (indocyanine green for injection, USP), 25 mg Product is being recalled due to low pH value. Class IIIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01) Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally… Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine Tablets, 2.5 mg, 1000-count bottles Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). Class IIIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 17, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Olanzapine Tablets, 7.5 mg Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). Class IIIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 17, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Olanzapine Tablets, 10 mg Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). Class IIIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 17, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Olanzapine Tablets, 20 mg Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). Class IIIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 17, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle Failed Stability Specifications Class IIIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mozobil (plerixafor injection) 24mg/1.2mL Labeling: Incorrect or Missing Package Insert Class IIIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2017ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100… Microbial Contamination of Non-Sterile Products Class IIFDA’s classMay 17, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton Failed Dissolution Specifications Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton Failed Dissolution Specifications Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication FDA Class I, its most serious class Class IFDA’s class (needs attention)May 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication FDA Class I, its most serious class Class IFDA’s class (needs attention)May 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Aripiprazole Tablets, 2 mg, 30 count unit dose box Superpotent Drug; out of specification results for assay (manufacturer) Class IIIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle… Failed Dissolution Specifications Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point. Class IIIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. Class IIIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor Failed Dissolution Specifications Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12,… Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4% Failed Impurities/Degradation Specifications. Class IIIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pilocarpine Hydrochloride Ophthalmic Solution 4% Failed Impurities/Degradation Specifications. Class IIIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Donepezil HCl tablets, 10mg Supotent: Out of Specification result for assay test during routine stability testing. Class IIIFDA’s classMay 3, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 3, 2017ClassClass IIIStatusTerminatedWhereColorado, Louisiana and Ohio
- Medicine recall Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Class IIFDA’s classMay 3, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
Nothing matches all of these.
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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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