Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 11,681–11,700 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,

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

5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48

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

4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-214-48

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

4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48

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

4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), 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

3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30

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

3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), 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

3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), 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

3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), 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

3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97

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

20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48

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

20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96

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

20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61

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

20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12

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

20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48

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

2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02

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

2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48

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

2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), 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

2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48

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

2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50

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 →

Data last updated:

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.