Medicines, 2016
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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 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.15% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.2% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.25% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.5% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
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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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