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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 3,001–3,020 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11

by Amerisource Health Services LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass II

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41

by Leadiant Biosciences, Inc.

Reason
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Recall initiated
February 3, 2023
Reported by FDA
February 22, 2023
Distribution
Nationwide USA

View recall →

Drug Recall Ongoing Historical recordClass II

Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.

by Consolidated Chemical, Inc

Reason
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Recall initiated
January 10, 2023
Reported by FDA
February 22, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02

by Consolidated Chemical, Inc

Reason
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Recall initiated
January 10, 2023
Reported by FDA
February 22, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML, (f) 500 MG NS 100ML, (g) 750 MG NS 150ML, antibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN: AA 60GM ; DEX 200GM ; LIP 30GM IN 1500 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA ; 255GM/DEX ; 50GM/LIP 3500 ml, (i) 90GM/AA ; 255GMDEX 3500 ml, (j) TPN AA 100GM DEX: 320GM LIP: 50GM 2400ML, (k) TPN AA 30GM DEX: 145GM 1210ML, (l) TPN AA 30GM DEX: 145GM LIP: 35GM 1210ML, (m)TPN AA 42GM DEX: 432GM 2070ML, (n) TPN AA 50GM DEX: 130GM 2500ML, (o) TPN AA 55GM DEX:180GM 1000ML, (p) TPN AA 70GM DEX:290GM 2100ML, (q) TPN AA 70GM DEX:290GM 2500ML, (r) TPN AA 80GM DEX:200GM 1900ML, (s) TPN AA 80GM DEX:200GM LIP:38GM 1900ML, (t) TPN AA 30GM ; DEX 82GM ; IN 890 ml, (u) TPN AA 30GM ; DEX 82GM ; LIP 18GM IN 890 ml, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320

by Sentara Infusion Services

Reason
Lack of sterility assurance
Recall initiated
December 27, 2022
Reported by FDA
February 22, 2023
Distribution
Dispensed to Patients 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.