Lower riskDrug recall · FDA · Published March 13, 2025
Dr. Reddy's Levetiracetam Injection Label Mix-Up Recall
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.
Take action
Contact the company
📍Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
“Dr. Reddy's Levetiracetam Injection Label Mix-Up Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32194-dr-reddy-s-levetiracetam-injection-label-mix-up-recall. Based on FDA recall #D-0365-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0365-2025%22&limit=1).
The FDA announced on March 13, 2025, that Dr. Reddy's Laboratories, Inc. is recalling Levetiracetam 0.75% in Sodium Chloride Injection due to a labeling mix-up hazard. The infusion bags are incorrectly labeled as containing a different concentration of the drug than what is listed on the overwrap packaging.
How to tell if you have it
Brand: Dr. Reddy's
Product: Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL)
NDC: 43598-636-52
Lot: A1540076
Expiration Date: 08/31/2026
Quantity: 4,010 bags
The hazard
The hazard involves a labeling error where the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL. The aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Context
GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since April 9, 2012. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (Nov. 11, 2025), Dr. Reddy's Succinylcholine Chloride Injection Recall (Sept. 26, 2025), and Dr. Reddy's Omeprazole Capsules Recall (June 30, 2025). Other recent recalls of similar products include American Regent Levocarnitine Injection Recall (April 16, 2026), Hikma Alendronate Sodium Oral Solution Recall (April 7, 2026), and Fresen: Morphine Syringes May Have Wrong Labeling - Risk of Incorrect Medication (Aug. 4, 2026).
How to tell if you have this one
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.
Brand
Dr. Reddy's
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Labeling
Verify the product label matches the correct concentration: 1,000 mg/100 mL (10 mg/mL) in 0.75% Sodium Chloride Injection.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0365-2025 (March 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0365-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.