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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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Showing 11,661–11,680 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.

by Teva North America

Reason
Failed Tablet/Capsule Specifications
Recall initiated
May 18, 2016
Reported by FDA
August 3, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09

by Actavis Inc

Reason
Failed Dissolution Specifications
Recall initiated
July 11, 2016
Reported by FDA
August 3, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.

by Medicap Pharmacy

Reason
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Recall initiated
July 7, 2016
Reported by FDA
August 3, 2016
Distribution
ID

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Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
June 27, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,

by GlaxoSmithKline, LLC

Reason
Penicillin Cross Contamination
Recall initiated
July 18, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide and PR.

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Drug Recall Terminated Historical recordClass II

Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.

by GlaxoSmithKline, LLC

Reason
Penicillin Cross Contamination
Recall initiated
July 18, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide and PR.

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Drug Recall Terminated Historical recordClass II

Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,

by GlaxoSmithKline, LLC

Reason
Penicillin Cross Contamination
Recall initiated
July 18, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide and PR.

View recall →

Drug Recall Terminated Historical recordClass II

Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,

by GlaxoSmithKline, LLC

Reason
Penicillin Cross Contamination
Recall initiated
July 18, 2016
Reported by FDA
July 27, 2016
Distribution
Nationwide and PR.

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Drug Recall Terminated Historical recordClass II

8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50

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

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Drug Recall Terminated Historical recordClass II

6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86

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

6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86

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 HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20

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 HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54

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 HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), 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

5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61

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

5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52

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

5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), 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

5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20

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 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), 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

5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag ; Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 4J8136 , NDC 61553-136-97 , 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 →

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.