Levetiracetam 0 — Class I drug recall D-0365-2025
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2025-04-23, distributed nationwide. LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Inje
| Recall number | D-0365-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2025-03-13 |
| Classified | 2025-04-16 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 4,010 bags |
| Reason classes | labeling |
| NDC | 43598-0635, 43598-0635-10, 43598-0635-52, 43598-0636, 43598-0636-10, 43598-0636-52, 43598-0637, 43598-0637-10, 43598-0637-52 |
| Lot numbers | A1540076 |
| Expiration dates | 2026-08-31 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0365-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.