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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 16,601–16,620 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12

by Procter & Gamble Co

Reason
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
Recall initiated
August 29, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183

by Medaus, Inc.

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

by JCB Labs LLC

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide and Guam

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Drug Recall Terminated Historical recordClass II

Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.

by JCB Labs LLC

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide and Guam

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

by JCB Labs LLC

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide and Guam

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Laboratories, Wichita, KS.

by JCB Labs LLC

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide and Guam

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.

by JCB Labs LLC

Reason
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Recall initiated
August 23, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide and Guam

View recall →

Drug Recall Terminated Historical recordClass II

IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.

by Dr. Reddy's Laboratories, Inc.

Reason
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Recall initiated
August 29, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide (& Puerto Rico)

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Drug Recall Terminated Historical recordClass II

Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

by Leiter's Pharmacy

Reason
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Recall initiated
August 26, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

by Leiter's Pharmacy

Reason
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.
Recall initiated
August 26, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

by Leiter's Pharmacy

Reason
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Recall initiated
August 26, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

by Leiter's Pharmacy

Reason
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Recall initiated
August 26, 2013
Reported by FDA
September 25, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA 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.