The Recall Desk
ModerateFDA (Drugs)·D-1233-2020·Announced 2020-04-22

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.

What this means for you

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
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.

See all 9 products in this recall →