Dr. Reddy's Laboratories, Inc. 2025-04-23 Health critical FDA
Health · FDA · Recall #FDA-D-0365-2025
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL,… Recall
Issued April 23, 2025 · Dr. Reddy's Laboratories, Inc.
In April 2025, Dr. Reddy's Laboratories, Inc. recalled the Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Dr. Reddy's Laboratories, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Dr. Reddy's Laboratories, Inc.
- Category
- Health
- Recall date
- April 23, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0365-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Dr. Reddy's Laboratories, Inc. has 17 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.