Levetiracetam Injection Label Mismatch Nationwide Recall
Dr. Reddy's Laboratories is recalling Levetiracetam 0.75% Sodium Chloride Injection due to a labeling discrepancy where the infusion bag is incorrectly labeled as 0.82% Sodium Chloride 500 mg/100 mL instead of the correct 0.75% Sodium Chloride 1,000 mg/100 mL.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a prescription injectable drug with a labeling discrepancy that could result in incorrect dosing—a serious medication error risk. Although no illnesses are reported in the source, Class I recalls are inherently classified as Severe or Critical per the rubric, and this defect creates potential for patient harm through dosing confusion.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Levetiracetam (Levetiracetam Injection) 0.75% in Sodium Chloride Injection, 1,000 mg/100 mL, supplied in 100 mL bags (Lot A1540076, expiration date 08/31/2026). The recall affects 4,010 bags distributed nationwide in the USA.
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. This labeling mix-up could lead to dosing errors or confusion during preparation and administration.
Healthcare providers and patients who have received this product should verify the actual product contents against the aluminum overwrap packaging and consult their healthcare provider if they have any concerns about doses already administered. The product should not be used and should be returned to the distributor.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM INJECTION)
- Brand
- LEVETIRACETAM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Injectable / Infusion
- Hazard
- labeling-error
- dosing-confusion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: A1540076
- Exp 08/31/2026
Distribution
Distributed nationwide across the United States.
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