Aurobindo Recalls Levetiracetam Tablets Due to Manufacturing Water Leakage
Aurobindo Pharma is recalling 8,040 bottles of Levetiracetam 750 mg tablets because they were manufactured in an area with observed water leakage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations (water leakage) without reported illnesses or injuries, fitting the criteria for a voluntary precautionary recall or minor process error.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling 8,040 units of Levetiracetam Tablets USP 750 mg, 120-count bottles. The affected product is identified by Lot # 24719001A1 and an expiration date of 03/2021. The product is distributed nationwide within the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured in a processing area where water leakage was observed. This condition may have compromised the manufacturing environment.
Consumers who have this specific lot of Levetiracetam should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM)
- Brand
- LEVETIRACETAM
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Anticonvulsant
- Affected units
- 8,040
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 24719001A1
- Exp. Date 03/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Aurobindo Pharma USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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