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 Testosterone 50 mg pellet Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Testosterone 55 mg pellet Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Testosterone 80 mg pellet Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Testosterone/Anastrozole 200 mg/20 mg pellets Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Testosterone/Anastrozole 60 mg/1 mg pellets Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Testosterone/Anastrozole 60 mg/4 mg pellets Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 10 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 12.5 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 15 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 20 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 25 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 35 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 40 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 50 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Estradiol 55 mg (SD) pellets in amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Testosterone/Finasteride 80 mg/8 mg pellet, amber vial Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNevadathe one state its words name PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. Class IIIFDA’s classApr 25, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 25, 2018ClassClass IIIStatusTerminatedWherePennsylvania
- Medicine recall Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( Superpotent Drug Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 cGMP Deviations Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Molleave, 2 oz bottle, OTC cGMP Deviations Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz cGMP Deviations Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zhong Hua Jiu (menthol 1%) Patch CGMP Deviations: the product was produced with substandard GMP manufacturing processes. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tramadol Hydrochloride 50 mg tablets, 120-count Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classApr 18, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 18, 2018ClassClass IIIStatusTerminatedWhereFlorida and Virginia
- Medicine recall Decitabine for Injection, 50mg per vial Failed impurities/degradation specifications: Failure to water content and impurity Class IIIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fabior (tazarotene) Foam, 0.1%, 100 grams can Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point. Class IIIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles Failed Dissolution Specifications; during stability testing Class IIIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count… Failed Dissolution Specifications; during stability testing Class IIIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Flucanazole Injection, USP 200 mg in Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability Class IIIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Indomethacin Capsules USP, 50 mg, 100-count bottle Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of “One or two capsules 2 or 3 times a day.” rather than the correct… Class IIIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly… Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall E-Z-Paste Barium Sulfate Esophageal Cream Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL Presence of particulate matter Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. Class IIIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution,… Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. Class IIIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution,… Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. Class IIIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IStatusTerminatedWhereNo state named
- Medicine recall DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355… Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect… Class IIIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMar 28, 2018ClassClass IIIStatusTerminatedWhereNew York
- Medicine recall Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class IIIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 28, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Estradiol Vaginal Inserts, USP 10 mcg Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 28, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%) Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period. Class IIIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 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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