Levetiracetam 0.75% in Sodium Chloride Injection 1 recall: Labeling Error
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad…
Why was Levetiracetam 0.75% in Sodium Chloride Injection 1 recalled?
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: A1540076, Exp 08/31/2026
- Product
- Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad…
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 4,010 bags
- Distribution
- Nationwide in the USA
- Recall date
- April 23, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)