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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 10,341–10,360 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-239-01

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-03

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33

by AbbVie Inc.

Reason
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Recall initiated
September 8, 2017
Reported by FDA
November 1, 2017
Distribution
AZ

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Drug Recall Terminated Historical recordClass I

Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58

by Baxter Healthcare Corporation

Reason
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Recall initiated
September 15, 2017
Reported by FDA
November 1, 2017
Distribution
Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11

by Becton Dickinson & Company

Reason
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Recall initiated
September 15, 2017
Reported by FDA
November 1, 2017
Distribution
IL, MO, PA, TN, & VA

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Drug Recall Terminated Historical recordClass II

VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass III

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Cross contamination with other products: traces of Dapsone were found in the finished product.
Recall initiated
September 20, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-245-04

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-245-03

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-243-04

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-02

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
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.