# Major Recall Alert: Levetiracetam in Sodium Chloride Injection Recalled Due to Mislabeling of Infusion Bag
Dr. Reddy's Laboratories, a global pharmaceutical company, has issued a nationwide recall in the United States for its Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL single-dose infusion bags. This vital medication, used to treat seizures, is being recalled over a **mislabeling issue** that poses significant safety risks to patients. In this blog, we’ll break down everything you need to know about this recall and how to protect yourself or your loved ones.
## Why This Recall is Important
Mislabeling of any drug product is a serious issue, but in this case, it could lead to **dangerous overdoses** with serious health consequences.
The product is **incorrectly labeled** as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL on the infusion bag, while the aluminum overwrap correctly identifies it as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. This mislabeling may lead to patients receiving **double the intended dosage**—a critical error in treatments requiring precise medication control.
### Risks of Receiving the Mislabeled Dose
Administering a double dose of intravenous levetiracetam could result in immediate and severe side effects, including:
- **Hypersensitivity reactions**
- **Liver injury**
- **Hematological toxicity**
- Somnolence or fatigue
- Dizziness and coordination difficulties
- Agitation, aggression, or depressed levels of consciousness
- **Respiratory depression** and coma
Patients receiving high doses of this medication via intravenous infusion, especially those treating conditions like status epilepticus, are at the greatest risk of serious adverse effects.
Fortunately, **no adverse events have been reported** so far, but vigilance is crucial.
## Details of the Recall
This recall affects **Batch/Lot No: A1540076** of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL). The product was distributed nationwide from **November 4, 2024, to November 6, 2024**, to wholesalers across the United States.
### Product Information:
- **Affected Batch/Lot Number**: A1540076
- **NDC**: Listed on the packaging for identification
- **Packaging**: Single-dose infusion bags with aluminum overwrap; cartons containing 10 single-dose bags
Dr. Reddy’s Laboratories, Inc., is notifying distributors and customers of this recall.
## What You Should Do
If you possess the recalled product or have distributed it, take the following steps immediately:
1. **Stop Use and Distribution**: Cease use of the product and quarantine it to prevent further distribution.
2. **Arrange a Return**: Contact your distributor or Inmar at **1-877-645-1584** (Monday–Friday, 9 a.m.–5 p.m. ET) to coordinate product return and replacement.
3. **Notify Affected Parties**: If you've further distributed the product to pharmacies or hospitals, make sure they’re aware of this recall.
4. **Monitor for Side Effects**: Patients who believe they’ve received a mislabeled dose should contact their healthcare provider promptly.
For consumers, contact Dr. Reddy’s Medical Information Call Center at **1-888-375-3784 (1-888-DRL-DRUG)** for guidance (Monday–Friday, 8 a.m.–8 p.m. ET).
You can also report side effects or quality issues to the **FDA MedWatch Adverse Event Reporting Program** online at [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
## Stay Safe – Get Instant Recall Alerts
Drug recalls can have life-threatening consequences if missed. Stay informed by regularly checking FDA announcements or using mobile apps designed to provide instant recall alerts for medications, food, and consumer products.
Take charge of your health and safety: **Download the FDA’s safety app now to get real-time recall alerts and updates directly on your phone.**
### Official Source:
For further details on the recall, visit the **FDA announcement** page [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-nationwide-recall-levetiracetam-075-sodium-chloride-injection-1000-mg100-ml-us-due).
Stay vigilant and prioritize your health—check your medical supplies and share this critical information with anyone who might be affected by this recall.