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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ;

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83

by PharMEDium Services, LLC

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recall initiated: May 5, 2016
Reported by FDA: July 27, 2016
Distribution: Nationwide

View recall →

Data last updated: September 25, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.