Medicines, 2019
Shortlist up to four to read them side by side.
2,152 medicine recalls FDA’s Enforcement Report published in 2019, 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.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isoproterenol HCL in D5W, 500mcg/50mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine 0.5%/Phenylephrine 0.75% P.F Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mitomycin Preservative Free Irrigation, 40mg/10mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Naloxone HCL Preserved INJ, 500mg/50mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate, 5mg/5mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL PF INJ Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCCINYLcholine Chloride, 100mg/5mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCCINYLcholine Chloride, 200mg/10mL Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process… Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Children’s Liquid, 160 mg/5 mL, 4 oz bottle Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class IIFDA’s classJul 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count… Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count… Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy &… Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy &… Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram… Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Myorisan (isotretinoin capsules, USP), 40 mg Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly. Class IIIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall QUIK-CARE Aerosol Foam Hand Sanitizer Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material. Class IIIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton GMP Deviations: Potential cross contamination due to cleaning procedure failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetirizine HCL Oral Solution 1 mg/mL, Children’s Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor,… cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetirizine Oral Solution 1 mg/mL, Children’s Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetirizine Oral Solution 1 mg/mL, Up & Up, Children’s allergy relief, Antihistamine, Dye Free, Grape Flavor,… cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to… Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Robafen DM, Generic for Robitussin DM, In each teaspoonful CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medicine recall ANASTROZOLE Tablets, 1 mg CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Anastrozole Tablets, USP, 1 mg, 1,000-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone Tablets, USP 16 mg, 50 tablets CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone Tablets, USP 32 mg, 25 tablets CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
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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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