The Recall Desk
ModerateFDA (Drugs)·D-0630-2021·Announced 2021-06-16

Levetiracetam Tablets 250 mg Recalled for Incorrect Barcode

McKesson Corporation is recalling Levetiracetam Tablets USP 250 mg due to a barcode error that could cause some units to be misread as Naproxen 500 mg, although the product label itself is correct.

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: This is an FDA Class III recall involving a labeling error (barcode mislabeling). Although the error could theoretically result in medication confusion, no illnesses, injuries, or hospitalizations are reported in the source text. Class III recalls with labeling errors are typically scored as 1 or 2; this scores as 2 because the barcode-label mismatch could potentially lead to medication dispensing errors.

Plain-English summary

McKesson Corporation is recalling Levetiracetam Tablets USP, 250 mg in UD 100-tablet boxes (10x10 cartons) distributed nationwide in the US. The recall affects 210 cartons with lot number 0000124916 (expiration 09/30/2022), NDC 63739-795-10. The product is manufactured by Aurobindo Pharma Limited in Hyderabad, India.

The recall is due to an error in the machine-readable barcode. The barcode on some units could be read as Naproxen Tablets 500 mg instead of Levetiracetam 250 mg, despite the product label being correct. This mismatch between barcode and label could lead to medication errors.

Patients and healthcare providers should not use affected units and should contact their pharmacy or McKesson Corporation with questions about the recall. The product is dispensed by prescription only.

The recalled product

Product
Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10
Manufacturer
McKesson Corporation dba McKesson Drug Company
Hazard
  • barcode-error
  • mis-labeling
  • medication-confusion

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 (1)

  • Lot: 0000124916 Exp. 09/30/2022

Distribution

Distributed nationwide across the United States.