Levetiracetam 0.75% in Sodium Chloride Injection 1 recall
FDA recall D-0365-2025 · initiated Mar 13, 2025
Dr. Reddy's Laboratories, Inc. recalled Levetiracetam 0.75% in Sodium Chloride Injection 1 in Mar 2025 — an FDA Class I recall (D-0365-2025) because 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.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was 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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,010 bags
Details
- 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, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 13, 2025
- FDA report date
- Apr 23, 2025
Frequently asked
- Was Levetiracetam 0.75% in Sodium Chloride Injection 1 recalled?
- Dr. Reddy's Laboratories, Inc. recalled Levetiracetam 0.75% in Sodium Chloride Injection 1 in Mar 2025 — an FDA Class I recall (D-0365-2025) because 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. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Levetiracetam 0.75% in Sodium Chloride Injection 1 recalled?
- Per the FDA enforcement record, the reason for recall D-0365-2025 was: 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.
- Is a recalled Levetiracetam 0.75% in Sodium Chloride Injection 1 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Levetiracetam 0.75% in Sodium Chloride Injection 1 are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: A1540076, Exp 08/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0365-2025.