Class II · Moderate risk
Levetiracetam Oral Solution 100 mg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Levetiracetam 0.75% in Sodium Chloride Injection 1 (Levetiracetam Injection)
Class I — High risk. Reasonable probability of serious harm or death.
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
43598-0636-52
Compare with the code on your package — it is the most precise check available.
Drug: Levetiracetam
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Levetiracetam Levetiracetam Injection NDC 43598-0636 |
LEVETIRACETAM 10 mg/mL | Injection Intravenous |
Dr.Reddy's Laboratories Inc | Rx |
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 43598-636-52
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Mar 13, 2025 · FDA notice with lot numbers
- FDA recall number
- D-0365-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Levetiracetam recalls
See all
Class III · Low risk
Levetiracetam Tablets USP
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Class II · Moderate risk
Levetiracetam Oral Solution
Defective container: Customer complaints for oral solution leaking from bottles.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk
Levetiracetam Tablets USP 750 mg 120-count bottles
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Other recalls by Dr. Reddy's Laboratories, Inc.
All 2025 recalls
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class III · Low risk
Javygtor (sapropterin dihydrochloride)
Failed Impurities/Degradation Specifications
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