Medicines, 2017
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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 fentaNYL 3 mcg/mL + BUPIvacaine 0.1% 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 Hydromorphone 0.5 mg/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 ePHEDrine Sulfate 5 mg/mL in NS 5 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 EPINEPHrine HCl 4 mg 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 NORepinephrine 4 mg 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 NORepinephrine Bitartrate 8 mg 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 NORepinephrine Bitartrate 16 mg 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 PHENYLephrine HCl 60 mg 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 PHENYLephrine HCl 25 mg 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 PHENYLephrine HCl 10 mg 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 PHENYLephrine 10 mg 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 PHENYLephrine 40 mg 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 PHENYLephrine 100 mg 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 PHENYLephrine 200 mg 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 PHENYLephrine 20 mg 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 PHENYLephrine 50 mg 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 Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 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 Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 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 + Ropivacaine 0.2% PF in NS 250 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 Argatroban Injection, 250 mg/2.5 mL Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point Class IIIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mefenamic Acid, 250mg capsules Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class IIIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class IIIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. Class IIIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity. Class IIIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD… Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium PHOSphate Lack of Assurance of Sterility; media fill failure at manufacturer Class IIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Obagi-C Rx System C-Therapy Night Cream Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. Class IIIFDA’s classJul 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial… Lack of Assurance of Sterility Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265… Lack of Assurance of Sterility Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265… Lack of Assurance of Sterility Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265… Lack of Assurance of Sterility Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag Lack of Assurance of Sterility: Customer complaints for leaking bags. Class IIFDA’s classJul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 19, 2017ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall EliquisTablets 5mg, 60 count bottle Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2017ClassClass IStatusTerminatedWhereNationwide
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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