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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 12,461–12,480 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

by Bausch & Lomb, Inc.

Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Recall initiated
January 18, 2016
Reported by FDA
February 3, 2016
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

by Bausch & Lomb, Inc.

Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Recall initiated
January 18, 2016
Reported by FDA
February 3, 2016
Distribution
U.S. Nationwide including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

View recall →

Drug Recall Terminated Historical recordClass II

ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

by Sentara Enterprises

Reason
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Recall initiated
September 18, 2015
Reported by FDA
February 3, 2016
Distribution
U.S. Including: VA, NC

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.