FDA Drug recall D-0365-2025
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, Hyd…
- FDA Drug
- Class I
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class I recall of 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, Hyd… by Dr Reddy S Laboratories, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0365-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-03-13 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
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.
Identifiers
| ndc | 43598-635-52 |
|---|---|
| ndc | 43598-635-10 |
| ndc | 43598-636-52 |
| ndc | 43598-636-10 |
| ndc | 43598-637-52 |
| ndc | 43598-637-10 |
| code_info | Lot: A1540076, Exp 08/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Dr Reddy S Laboratories
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-90…
FDA Drug · Class III · 2025-12-17 · Dr Reddy S Laboratories - Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx…
FDA Drug · Class II · 2025-10-15 · Dr Reddy S Laboratories - Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally -…
FDA Drug · Class II · 2025-07-23 · Dr Reddy S Laboratories - Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ…
FDA Drug · Class III · 2024-12-18 · Dr Reddy S Laboratories - IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India,…
FDA Drug · Class III · 2024-11-27 · Dr Reddy S Laboratories
All Dr Reddy S Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0365-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.