Levetiracetam Injection Label Mix-up May Cause Incorrect Dosing
Dr. Reddy's Laboratories is recalling Levetiracetam Injection (Class I) due to a labeling mix-up where the infusion bag label does not match the aluminum overwrap, creating a risk of medication error.
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 drug recall, which requires a minimum severity score of 4 per the rubric. The labeling mix-up between the bag label and aluminum overwrap creates a significant risk of medication dosing error for intravenous administration.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Levetiracetam 0.75% in Sodium Chloride Injection (1,000 mg/100 mL) distributed nationwide. The recall affects 4,010 bags from Lot A1540076, with expiration date 08/31/2026 (NDC 43598-636-52).
The infusion bag label incorrectly identifies the product as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL. However, the aluminum overwrap packaging correctly identifies it as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. This labeling discrepancy creates confusion about the actual concentration and dose of the medication.
Healthcare providers using the incorrect bag label could administer the wrong concentration and dose of the medication. No illnesses or injuries have been reported. Healthcare facilities that received this lot should quarantine affected bags immediately and verify product identity using the aluminum overwrap label before administration. Contact Dr. Reddy's Laboratories, Inc. or the FDA with any questions or to report adverse events.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM INJECTION)
- Brand
- LEVETIRACETAM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Injectable
- Hazard
- label-mix-up
- medication-error
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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