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 Diltiazem HCl 125 mg Lack of Sterility Assurance. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL Lack of Sterility Assurance. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq Lack of Sterility Assurance. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug… Lack of Sterility Assurance. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL Lack of Sterility Assurance. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL Lack of Sterility Assurance. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL Presence of Particulate Matter: Silicone oil Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL Presence of Particulate Matter: Silicone oil Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL Presence of Particulate Matter: Silicone oil Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amantadine HCl Capsules, USP, 100 mg Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportKentuckythe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereKentucky
- Medicine recall Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportKentuckythe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereKentucky
- Medicine recall Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups Labeling Error: Label mix-up. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereConnecticut and Ohio
- Medicine recall Pravastatin Sodium Tablets, USP, 10 mg Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220. Class IIIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Albuterol Sulfate Inhalation Solution, 0.021% Failed Impurities/Degradation Specifications: high out of specification results for related compound D. Class IIIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 9, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials CGMP Deviations Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Failed Dissolution Specifications Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count… Failed Dissolution Specifications Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count… Failed Dissolution Specifications Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg… Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Phosphates Inj., USP, 45 mM Lack of Sterility Assurance Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq Lack of Sterility Assurance Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Succinylcholine Chloride Injection, USP 200 mg Lack of Sterility Assurance Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Neut Sodium Bicarbonate 4% Lack of Sterility Assurance Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 9, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Alka-Seltzer Extra Strength Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alka-Seltzer Gold Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Louisiana, New Hampshire, Ohio, Pennsylvania and South Carolina
- Medicine recall Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Louisiana, New Hampshire, Ohio, Pennsylvania and South Carolina
- Medicine recall Magnesium Citrate Oral Solution Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereGeorgia, New Jersey and Pennsylvania
- Medicine recall Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped) Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Famotidine Tablets USP, 20 mg, 100 count bottles Failed Tablet/Capsule Specification; out of specification for tablet weight Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By Failed Tablet/Capsule Specification: out of specification for tablet weight. Class IIFDA’s classAug 9, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine sulfate 1 mg per mL Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL (as citrate) 10 mcg per mL Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem 125 mg Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include… Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 10 mg Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVacaine HCl 0.1% PF (From 0.75%) Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVacaine HCl 0.125% Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVacaine HCl 0.2% Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL (as citrate) 5 mcg/mL Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL (as citrate) 10 mcg per mL Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL as citrate 5 mcg/mL Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 10 mcg/mL PF in NS 1 mL Fill Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg) Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF Lack of Assurance of Sterility; product has the potential to leak. Class IIFDA’s classAug 2, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2017ClassClass 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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