Dr. Reddy's Laboratories, Inc. recalls Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL
Dr. Reddy's recalls Levetiracetam injection due to label error showing incorrect strength. The product may be mislabeled as 0.75% Sodium Chloride (1000 mg/100 mL) when it's actually 0.54% Sodium Chloride (1500 mg/100 mL).
Lower-risk recall
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Contact the company & request your remedy
What happened, in plain English
Dr. Reddy's has recalled Levetiracetam injection because the product label incorrectly states the strength. This error could lead to incorrect dosing if the product is used as intended. Read more at govinfonow.com/recall/39474-dr-reddy-s-levetiracetam-injection-recall-label-error-on-strength.
Source Summary by GovInfoNow · govinfonow.com/recall/39474-dr-reddy-s-levetiracetam-injection-recall-label-error-on-strength · Updated October 5, 2026 · FDA enforcement record: FDA #D-0485-2019
Cite this page
“Dr. Reddy's Levetiracetam Injection Recall: Label Error on Strength.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39474-dr-reddy-s-levetiracetam-injection-recall-label-error-on-strength. Based on FDA recall #D-0485-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0485-2019%22&limit=1).
Why it’s dangerous
The label error means the product is misidentified as 0.75% Sodium Chloride (1000 mg/100 mL) when it's actually 0.54% Sodium Chloride (1500 mg/100 mL). This could lead to incorrect dosing if the product is used without verifying the correct strength.
Who’s affected
Patients using this specific Levetiracetam injection product may be affected. Those who have the product with the incorrect label are at risk of receiving the wrong dosage.
How to tell if you have this one
Check for the product name 'Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL)' on the primary infusion bag. The NDC number is 43598-637-52 and it was manufactured by Gland Pharma Limited in Hyderabad, India.
- Brand
Dr. Reddy's- Product
Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL- Category
Drug
What to do — step by step
Verify Product Label
Check the primary infusion bag for the correct product name and strength as listed in the recall notice.
Questions people ask
Is this product dangerous?
The product is not dangerous but has a label error that could lead to incorrect dosing if not verified.
How can I tell if I have the recalled product?
Look for the product name 'Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL)' on the primary infusion bag, with NDC 43598-637-52.
What should I do if I have this product?
Verify the product label to ensure it matches the correct strength. If there's a discrepancy, contact Dr. Reddy's for guidance.
Contact Dr. Reddy's
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-0485-2019 — Dr. Reddy's Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intrave Hello, I own a Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL that is covered by recall D-0485-2019 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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Where this comes from
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.
- Official source: FDA Recall #D-0485-2019 (October 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0485-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.