Medicines, 2016
Shortlist up to four to read them side by side.
1,254 medicine recalls FDA’s Enforcement Report published in 2016, 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.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Morphine Sulfate (PF) 0.5mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Morphine Sulfate 1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Hydromorphone HCI 0.2mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 10mcg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 25 mcg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ketamine 50mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Cefazolin 2GM added to 5% Dextrose 50 mL USP Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Provocholine pre-diluted Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 25mcg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Hydromorphone HCI 0.4mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall HYDROmorphone HCI 0.2mg/ml Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ketamine 100mg/mL 1mL fill 3 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Midazolam HCI1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Epinephrine HCI 5 mcg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall HYDROmorphone HCI 0.4mg/ml Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall HYDROmorphone HCI 0.4mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Morphine Sulfate (Preserved) 2mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Diltiazem HCI 250 mg Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Norepinephrine Bitartrate 4 mg Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Hydromorphone HCI 1 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 10 mcg/mL(PF) Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Morphine Sulfate 1 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Morphine Sulfate 1mg/mL (Preserved) Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Morphine Sulfate (PF) 1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Bupivacaine HCI 0.125% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ketamine 20 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Phenylephrine HCI100mcg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall HYDROmorphone HCI 1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall HYDROmorphone HCI 0.2 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
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.
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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