US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

      Summary Company Announcement Date: July 10, 2025 FDA Publish Date: July … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

February 4, 2019 By The FDA Leave a Comment

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

The recall, which began in October 2018, was originally initiated due to a product complaint received for mislabeling. The pre-printed text content on the infusion bag (primary container) for the lot indicates product information as Levetiracetam in 0.75% Sodium Chloride Injection (1000mg/100ml). The label on the external foil pouch has the product information as Levetiracetam in 0.54% Sodium Chloride Injection (1500mg/100ml). To date, there have been no reports of adverse events related to this recall.

Patients who may have been administered the mislabeled product could experience adverse reactions such as somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma related to over dosage.

Levetiracetam Injection is an antiepileptic drug indicated for adjunct therapy in adults (more than 16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures, Myoclonic seizures inpatients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures.

The batch was distributed in U.S.A. between August 14, 2018 and September 5, 2018.

The recalled batch is as follows:

Item Description Manufacturer NDC Lot Expiry
 Date
Levetiracetam in 0.54% Sodium chloride Injection, 1500mg/100mL Gland Pharmaceuticals 43598-637-52 ABD807 05/2020

Dr Reddy’s Laboratories, Inc has notified the distributors to arrange for return of any recalled product. Wholesalers, distributors, hospitals and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement/etc. of all recalled products. Wholesalers, distributors and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. For instructions on returning product or additional assistance, call Inmar at 1-800-967-5952 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

If patients have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 10 p.m. ET, Monday through Friday. Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

 Important Safety Information: Levetiracetam in Sodium Chloride Injection

What important information should I know about Levetiracetam in Sodium Chloride Injection?

  • Levetiracetam is an antiepileptic drug indicated for adult patients 16 years of age and older when oral administration is temporarily not feasible.
  • Treatment with Levetiracetam may cause changes in behavior such as aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, and psychotic symptoms.
  • Levetiracetam may cause drowsiness, sleepiness, and fatigue.
  • Levetiracetam may cause serious dermatological reactions. Levetiracetam should be discontinued at the first sign of rash.
  • Levetiracetam should be gradually withdrawn to minimize potential of increased seizure frequency.
  • Levetiracetam blood levels may decrease during pregnancy. It is recommended that patients be monitored carefully during pregnancy.

Who should not use Levetiracetam in Sodium Chloride Injection?

  • Patients with a known hypersensitivity to levetiracetam should not take this drug as angioedema and anaphylaxis have been reported.

What should I tell my healthcare provider before taking Levetiracetam in Sodium Chloride Injection?
Before taking Levetiracetam in Sodium Chloride Injection, tell your healthcare provider if you:

  • Have or have had suicidal thoughts or behavior
  • Have or have had kidney problems
  • Become pregnant or intend to become pregnant
  • Are nursing

Tell your healthcare provider about all medications and herbal products you take, including prescription and over-the-counter medications, vitamins and herbal supplements.

What are possible side effects of Levetiracetam in Sodium Chloride Injection?

  • Headache
  • Pain
  • Depression
  • Nervousness
  • Ataxia
  • Vertigo
  • Amnesia
  • Anxiety
  • Pharyngitis
  • Rhinitis
  • Diplopia
  • Fatigue

These are not all the possible side effects of Levetiracetam. Please refer to the Package Insert for a complete list of possible side effects.
Call your healthcare provider right away if you have any of the following:

  • Changes in mood or behavior
  • Signs or symptoms of an allergic reaction or increased swelling
  • Signs or symptoms of a rash

The most common side effects of Levetiracetam in Sodium Chloride Injection?

  • Drowsiness
  • Sleepiness
  • Fatigue
  • Infection
  • Dizziness

What should I avoid while taking Levetiracetam in Sodium Chloride Injection?

  • Avoid driving or operating machinery until you know how levetiracetam affects you as levetiracetam may cause dizziness and sleepiness.

For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy’s Laboratories Medical Information Call Center at 1-888-DRL-DRUG (1-888-375-3784) or via email to medinfo@drreddys.com or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.fda.gov/medwatch/report.htm.

Indication and Usage
Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of:

  • Partial onset seizures in adults with epilepsy,
  • Myoclonic seizures in adults with juvenile myoclonic epilepsy,
  • Primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.

Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose 100 mL dual port bag with an aluminum overwrap.

###

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

July 10, 2025 By The FDA

Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination

July 10, 2025 By The FDA

Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards

July 9, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology

July 9, 2025 By The CPSC

AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA

July 9, 2025 By The CPSC

Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm

July 9, 2025 By The CPSC

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

CHS Inc. Recalls Payback Champion Lamb Feed Due to Elevated Copper Health Risk

July 9, 2025 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
  • Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination
  • Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards
  • WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE
  • Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard
  • SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology
  • AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA
  • Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm
  • Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in