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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 17,061–17,080 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass II

Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132

by Pentec Health

Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Recall initiated
May 15, 2013
Reported by FDA
June 12, 2013
Distribution
Dialysis Centers Direct to patient

View recall →

Drug Recall Terminated Historical recordClass III

Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60

by Legacy Pharmaceutical Packaging LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Recall initiated
March 27, 2013
Reported by FDA
June 12, 2013
Distribution
Distribution was made to IN.

View recall →

Drug Recall Terminated Historical recordClass II

Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN

by Petnet Solution Inc

Reason
cGMP Deviation
Recall initiated
February 22, 2013
Reported by FDA
June 12, 2013
Distribution
Within the state of CA.

View recall →

Drug Recall Terminated Historical recordClass III

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

by Teva Pharmaceuticals USA, Inc.

Reason
CGMP Deviation; cotton coil is missing in some packaged bottles
Recall initiated
March 19, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Recall initiated
February 19, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide and Puerto Rico, and Panama. Military distribution made.

View recall →

Drug Recall Terminated Historical recordClass III

Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Recall initiated
February 19, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide and Puerto Rico, and Panama. Military distribution made.

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.