[pending] LEVETIRACETAM (LEVETIRACETAM INJECTION)
Pending LLM rewrite. Source: FDA_DRUG D-0365-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM INJECTION)
- Brand
- LEVETIRACETAM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Drugs
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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