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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: A1540076, Exp 08/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0365-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 13, 2025
- FDA report date
- Apr 23, 2025
- Quantity
- 4,010 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0365-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96470
- Address
- 107 College Rd E
- Code information
- Lot: A1540076, Exp 08/31/2026
- Postal code
- 08540-6623
- Report date
- Apr 23, 2025
- Product type
- Drugs
- Recall number
- D-0365-2025
- Classification
- Class I
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 4,010 bags
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 13, 2025
- Center classification date
- Apr 16, 2025