Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Drug company (FDA labeler)

Baxter Healthcare Corporation

NDC labeler codes: 0338, 10019, 36000, 43066, 60977

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

92Prescription medicines
256Products (NDC)
113FDA applications
19Recalls

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
ApprovedApplicationMedicineSponsor
September 18, 2026ANDA219260 Rocuronium bromide
ROCURONIUM BROMIDE		Baxter Hlthcare Corp
September 11, 2026ANDA217072 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE		Baxter Hlthcare Corp
August 14, 2026NDA218524 Sodium bicarbonate
SODIUM BICARBONATE		Baxter Hlthcare Corp
August 6, 2026ANDA208458 Levetiracetam
LEVETIRACETAM		Baxter Hlthcare Corp
July 28, 2026ANDA219882 Diazepam
DIAZEPAM		Baxter Hlthcare Corp
July 8, 2026ANDA216740 Ephedrine sulfate
EPHEDRINE SULFATE		Baxter Hlthcare Corp
July 2, 2026ANDA217896 Levocarnitine
LEVOCARNITINE		Baxter Hlthcare Corp
April 15, 2026ANDA208103 Dexmedetomidine
DEXMEDETOMIDINE HYDROCHLORIDE		Baxter Hlthcare Corp
April 3, 2026ANDA217032 Phenylephrine
PHENYLEPHRINE HYDROCHLORIDE		Baxter Hlthcare Corp
March 30, 2026NDA220626 Epinephrine
EPINEPHRINE		Baxter Hlthcare Corp
February 26, 2026ANDA216852 Phytonadione
PHYTONADIONE		Baxter Hlthcare Corp
September 17, 2025ANDA219684 Ketamine hydrochloride
KETAMINE HYDROCHLORIDE		Baxter Hlthcare Corp
July 17, 2025ANDA219797 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE		Baxter Hlthcare Corp
February 28, 2025NDA218475 Epinephrine (epinephrine bitartrate)
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE		Baxter Hlthcare Corp
January 7, 2025ANDA216747 Dihydroergotamine mesylate
DIHYDROERGOTAMINE MESYLATE		Baxter Hlthcare Corp
September 24, 2024ANDA218878 Succinylcholine
SUCCINYLCHOLINE CHLORIDE		Baxter Hlthcare Corp
October 2, 2023ANDA217059 Levetiracetam
LEVETIRACETAM IN SODIUM CHLORIDE		Baxter Hlthcare Corp
September 29, 2023NDA216142 Micafungin
MICAFUNGIN IN SODIUM CHLORIDE 0.9%		Baxter Hlthcare Corp
September 29, 2023NDA217569 Vasopressin
VASOPRESSIN IN SODIUM CHLORIDE 0.9%		Baxter Hlthcare Corp
May 23, 2023ANDA217455 Regadenoson
REGADENOSON		Baxter Hlthcare Corp
February 28, 2023ANDA215744 Docetaxel
DOCETAXEL		Alembic
January 19, 2023ANDA207101 Sumatriptan
SUMATRIPTAN SUCCINATE		Baxter Hlthcare Corp
December 15, 2022NDA216078 Bendamustine hydrochloride
BENDAMUSTINE HYDROCHLORIDE		Baxter Hlthcare Corp
November 7, 2022ANDA214792 Naloxone hydrochloride
NALOXONE HYDROCHLORIDE		Baxter Hlthcare Corp
November 2, 2022ANDA214456 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Alembic
August 18, 2022ANDA210102 Ropivacaine hydrochloride
ROPIVACAINE HYDROCHLORIDE		Gland
July 14, 2022ANDA215065 Methocarbamol
METHOCARBAMOL		Baxter Hlthcare Corp
January 25, 2022NDA213645 Daptomycin
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE, DAPZURA RT		Baxter Hlthcare Corp
November 12, 2021ANDA206916 Palonosetron hydrochloride
PALONOSETRON HYDROCHLORIDE		Baxter Hlthcare Corp
September 17, 2021ANDA214331 Acetaminophen
ACETAMINOPHEN		Baxter Hlthcare Corp
April 22, 2021ANDA214379 Prochlorperazine
PROCHLORPERAZINE EDISYLATE		Caplin
April 21, 2021ANDA213001 Foscarnet sodium
FOSCARNET SODIUM		Gland
January 29, 2021ANDA214785 Naloxone hydrochloride
NALOXONE HYDROCHLORIDE		Baxter Hlthcare Corp
January 15, 2021NDA214313 Norepinephrine bitartrate
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE, NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE		Baxter Hlthcare Corp
August 11, 2020ANDA211965 Magnesium sulfate heptahydrate
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare Corp
June 1, 2020ANDA211966 Magnesium sulfate heptahydrate
MAGNESIUM SULFATE, MAGNESIUM SULFATE IN PLASTIC CONTAINER		Baxter Hlthcare Corp
April 9, 2020ANDA212808 Ropivacaine hydrochloride
ROPIVACAINE HYDROCHLORIDE		Caplin
March 25, 2020ANDA213232 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE		Caplin
December 13, 2019NDA212535 Cysteine hydrochloride
NOURESS		Baxter Hlthcare Corp
September 5, 2019ANDA211860 Fosaprepitant
FOSAPREPITANT DIMEGLUMINE		Baxter Hlthcare Corp
July 17, 2019ANDA212360 Tranexamic acid
TRANEXAMIC ACID		Caplin
June 20, 2019BLA208157 Insulin human
MYXREDLIN		Baxter Hlthcare Corp
September 15, 2017ANDA209900 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Baxter Hlthcare Corp
June 28, 2017ANDA208084 Clindamycin
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER		Baxter Hlthcare Corp
July 1, 2016ANDA206965 Tobramycin
TOBRAMYCIN SULFATE		Baxter Hlthcare Corp
August 7, 2015NDA207131 Cefazolin
CEFAZOLIN IN DEXTROSE		Baxter Hlthcare Corp
January 27, 2014ANDA202747 Furosemide
FUROSEMIDE		Baxter Hlthcare Corp
October 3, 2013NDA204508 Olive oil and soybean oil
CLINOLIPID 20%		Baxter Hlthcare Corp
June 5, 2013ANDA091436 Levofloxacin
LEVOFLOXACIN		Baxter Hlthcare Corp
April 29, 2013ANDA078950 Metoprolol
METOPROLOL TARTRATE		Baxter Hlthcare Corp
February 22, 2013ANDA078287 Ondansetron
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE		Baxter Hlthcare Corp
August 27, 2012ANDA091115 Rocuronium bromide
ROCURONIUM BROMIDE		Tamarang
June 29, 2011NDA201525 Docetaxel
DOCETAXEL		Sandoz
January 24, 2011ANDA078817 Oxaliplatin
OXALIPLATIN		Sandoz
December 24, 2008NDA022325 Amiodarone hydrochloride
NEXTERONE		Baxter Hlthcare
August 5, 2008NDA050817 Cefepime
CEFEPIME IN PLASTIC CONTAINER		Baxter Hlthcare
October 12, 2004ANDA076755 Flumazenil
FLUMAZENIL		Baxter Hlthcare Corp
July 5, 2002ANDA076051 Labetalol
LABETALOL HYDROCHLORIDE		Baxter Hlthcare Corp
July 2, 2002ANDA075895 Sevoflurane
SEVOFLURANE		Baxter Hlthcare
May 28, 2002ANDA075834 Milrinone lactate
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
May 10, 2001ANDA075591 Famotidine
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER		Baxter Hlthcare
April 21, 2000ANDA075323 Potassium chloride, sodium chloride, calcium chloride, and magnesium chloride
CARDIOPLEGIC IN PLASTIC CONTAINER		Baxter Hlthcare
August 26, 1998NDA020849 Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER		Baxter Hlthcare
February 24, 1998NDA050750 Piperacillin and tazobactam
ZOSYN IN PLASTIC CONTAINER		Baxter Hlthcare Corp
September 29, 1997NDA020734 Leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
August 30, 1996ANDA020512 Valine, lysine, histidine, isoleucine, leucine, phenylalanine, threonine, methionine, tryptophan, alanine, glycine, arginine, proline, glutamic acid, serine, aspartic acid and tyrosine
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER		Baxter Hlthcare
August 7, 1996NDA020248 I.v. fat emulsion
INTRALIPID 20%		Fresenius
November 17, 1995NDA050718 Doxorubicin hydrochloride
DOXIL (LIPOSOMAL)		Baxter Hlthcare Corp
December 30, 1993NDA019942 I.v. fat emulsion
INTRALIPID 30%		Fresenius
September 27, 1993NDA020255 Dobutamine in dextrose
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
April 29, 1993NDA050671 Vancomycin
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER		Baxter Hlthcare
December 7, 1992NDA020178 Sodium chloride
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		Baxter Hlthcare
December 7, 1992NDA020179 Dextrose monohydrate
DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
September 18, 1992NDA020118 Desflurane
SUPRANE		Baxter Hlthcare
January 30, 1992NDA019734 Nicardipine
CARDENE, CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER		Chiesi
July 2, 1991NDA020047 Dextrose monohydrate
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE 70% IN PLASTIC CONTAINER		Baxter Hlthcare
June 25, 1990NDA050638 Penicillin g
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER		Baxter Hlthcare
December 26, 1989NDA019904 Potassium chloride
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER		Baxter Hlthcare
October 31, 1989NDA050655 Nafcillin sodium
NALLPEN IN PLASTIC CONTAINER		Baxter Hlthcare
October 26, 1989NDA050640 Oxacillin
BACTOCILL IN PLASTIC CONTAINER		Baxter Hlthcare
August 14, 1987NDA019763 Ifosfamide
IFEX, IFEX/MESNEX KIT		Baxter Hlthcare
March 27, 1987NDA019615 Dopamine hydrochloride
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
December 31, 1986NDA019386 Esmolol hydrochloride
BREVIBLOC, BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, BREVIBLOC IN PLASTIC CONTAINER		Baxter Hlthcare
May 17, 1985NDA019319 Sodium chloride
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER		Baxter Hlthcare
April 5, 1985NDA019367 Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER		Baxter Hlthcare
August 23, 1984NDA018931 Leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine
TRAVASOL 10% IN PLASTIC CONTAINER, TRAVASOL 5.5% IN PLASTIC CONTAINER, TRAVASOL 8.5% IN PLASTIC CONTAINER		Baxter Hlthcare
November 1, 1983NDA019022 Sodium chloride
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
September 7, 1982ANDA062373 Gentamicin sulfate
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		Baxter Hlthcare
April 28, 1982NDA018609 Heparin sodium
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		Baxter Hlthcare
February 19, 1982NDA018494 Sodium chloride, sodium lactate, potassium chloride, and calcium chloride
LACTATED RINGER'S IN PLASTIC CONTAINER		Baxter Hlthcare
February 19, 1982NDA018495 Sodium chloride, potassium chloride, and calcium chloride
RINGER'S IN PLASTIC CONTAINER		Baxter Hlthcare
February 19, 1982NDA018508 Sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate
TIS-U-SOL		Baxter Hlthcare
February 19, 1982NDA018523 Acetic acid
ACETIC ACID 0.25% IN PLASTIC CONTAINER		Baxter Hlthcare
December 24, 1981NDA018657 Metronidazole
FLAGYL I.V. RTU IN PLASTIC CONTAINER		Baxter Hlthcare
April 22, 1981NDA018461 Lidocaine
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
January 23, 1981NDA018449 I.v. fat emulsion
INTRALIPID 20%		Fresenius
May 30, 1980NDA017863 Sorbitol
SORBITOL 3% IN PLASTIC CONTAINER		Baxter Hlthcare
May 30, 1980NDA017865 Glycine
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER		Baxter Hlthcare
May 30, 1980NDA017866 Water
STERILE WATER IN PLASTIC CONTAINER		Baxter Hlthcare
May 30, 1980NDA017867 Sodium chloride
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		Baxter Hlthcare
December 31, 1979NDA017874 Scopolamine
TRANSDERM SCOP		Baxter Hlthcare Corp
December 18, 1979NDA017624 Isoflurane
FORANE		Baxter Hlthcare
February 2, 1979NDA017378 Sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, PLASMA-LYTE A IN PLASTIC CONTAINER		Baxter Hlthcare
February 2, 1979NDA018016 Sodium chloride
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER		Baxter Hlthcare
December 31, 1974NDA017427 Sodium chloride
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		Baxter Hlthcare
December 31, 1974NDA017428 Water
STERILE WATER		Baxter Hlthcare
March 22, 1971NDA016679 Sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
March 4, 1971NDA016673 Dextrose monohydrate
DEXTROSE 5% IN PLASTIC CONTAINER		Baxter Hlthcare
January 25, 1971NDA016694 Dextrose monohydrate
DEXTROSE 10% IN PLASTIC CONTAINER		Baxter Hlthcare
December 9, 1970NDA016677 Sodium chloride
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER		Baxter Hlthcare
March 11, 1964NDA014134 Pralidoxime chloride
PROTOPAM CHLORIDE		Baxter Hlthcare Corp
November 16, 1959NDA012141 Cyclophosphamide
CYTOXAN		Baxter Hlthcare
—BN980123 Trisodium citrate dihydrate—

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2026

  1. August 6, 2026 · Class II · Ongoing · D-0814-2026 · Amiodarone hydrochloride

    CGMP Deviations

    Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 430

  2. August 6, 2026 · Class II · Ongoing · D-0818-2026 · Clindamycin

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-

  3. August 6, 2026 · Class II · Ongoing · D-0813-2026 · Nicardipine

    CGMP Deviations

    CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA

2025

  1. August 20, 2025 · Class II · Ongoing · D-0596-2025 · Acetaminophen

    Discoloration

    Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

2024

  1. October 30, 2024 · Class II · Ongoing · D-0039-2025 · Regadenoson

    Labeling: Missing Label

    Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation,

2023

  1. November 14, 2023 · Class II · Completed · D-0146-2024 · Ondansetron

    Failed pH Specifications

    Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 3822

  2. August 14, 2023 · Class III · Completed · D-1103-2023 · Bendamustine hydrochloride

    Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

    Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.

2022

  1. August 4, 2022 · Class II · Terminated · D-1348-2022 · Acetaminophen

    Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.

    Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60

  2. April 13, 2022 · Class II · Terminated · D-1083-2022 · Scopolamine

    cGMP deviations: Temperature abuse

    Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack, Rx only, MFG: Baxter Healthcare Corp, NDC 10019-553-03

2019

  1. June 13, 2019 · Class II · Terminated · D-1435-2019 · Sevoflurane

    Failed Stability Specifications

    Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64

2018

  1. October 15, 2018 · Class III · Terminated · D-0222-2019 · Metoprolol

    Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

    Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, Ind

  2. September 25, 2018 · Class III · Terminated · D-1215-2018 · Levofloxacin

    Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

    Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., Nor

  3. August 1, 2018 · Class III · Terminated · D-1034-2018 · Levofloxacin

    Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

    Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables

  4. August 1, 2018 · Class III · Terminated · D-1036-2018 · Levofloxacin

    Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

    Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectabl

  5. August 1, 2018 · Class III · Terminated · D-1035-2018 · Levofloxacin

    Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

    Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectabl

2017

  1. November 10, 2017 · Class I · Terminated · D-0573-2018 · Amiodarone hydrochloride

    Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged

    Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10

  2. March 10, 2017 · Class II · Terminated · D-0615-2017 · Levofloxacin

    Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

    Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24

2016

  1. April 12, 2016 · Class II · Terminated · D-0852-2016 · Esmolol hydrochloride

    Discoloration: presence of atypical yellow discoloration of the solution .

    Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87

2014

  1. June 16, 2014 · Class II · Terminated · D-1413-2014 · Esmolol hydrochloride

    Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

    Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →