CLASS III Drug recall · Reported 16 Jun 2021 · FDA Enforcement Report
Levetiracetam Tablets USP, 250 mg UD recalled by McKesson
McKesson is recalling Levetiracetam Tablets USP, 250 mg UD, distributed nationwide in the US. The recall was initiated on 26 May 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0630-2021
- FDA event ID
- 88008
- Recalling firm
- McKesson, Memphis, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 May 2021
- FDA classified
- 15 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 26 May 2021 | Recall initiated by company | |
| 15 Jun 2021 | Classified by FDA | +20 days |
| 16 Jun 2021 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot: 0000124916 Exp. 09/30/2022
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Levetiracetam recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution 100 mg/mL (100 mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution, 100 mg/mL recalled by Akorn | Akorn | Packaging Defects | Nationwide |
| Drug | CLASS II | Levetiracetam Tablets, USP 500 mg recalled by Eywa Pharma | Eywa Pharma | Packaging Defects | Nationwide |
| Drug | CLASS II | Levetiracetam Tablets USP 750 mg recalled by Aurobindo Pharma USALevetiracetam | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |