Dr. Reddy's recalls Levetiracetam 0.75% Sodium Chloride Injection due to incorrect labeling that could lead to wrong medication use. Affected units have specific NDC and lot numbers.
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.
Dr. Reddy's recalls a specific levetiracetam injection product because its labeling is incorrect. This mix-up could lead to using the wrong medication concentration, which might cause harm if administered.
The infusion bag is labeled as a different concentration (500 mg/100 mL) than the actual product (1,000 mg/100 mL). This mix-up could lead to administering too little medication if the wrong label is followed.
Prescription patients using the recalled levetiracetam injection. Healthcare providers who dispense the product are most at risk of administering the incorrect medication.
Check the NDC code 43598-636-52 and lot number A1540076 on the packaging. The product was manufactured by Gland Pharma Limited in Hyderabad, India.
Verify the product label matches the correct concentration: 1,000 mg/100 mL (10 mg/mL) in 0.75% Sodium Chloride Injection.
No, the product is safe when labeled correctly. The hazard is due to incorrect labeling, not the medication itself.
Check the label and NDC code. If the label shows 500 mg/100 mL, it is the incorrect product and should not be used.
Look for NDC 43598-636-52 and lot number A1540076 on the packaging. The product was manufactured by Gland Pharma Limited in Hyderabad, India.
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-0365-2025 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0365-2025 from Dr. Reddy's. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
