CLASS I Drug recall · Reported 25 Dec 2019 · FDA Enforcement Report
Levetiracetam Oral Solution 100mg/mL recalled by Lannett Company
Lannett is recalling Levetiracetam Oral Solution 100mg/mL, distributed nationwide in the US. The recall was initiated on 6 Dec 2019 and the FDA has classified it as Class I.
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-0630-2020
- FDA event ID
- 84427
- Recalling firm
- Lannett, Philadelphia, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Dec 2019
- FDA classified
- 27 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Seizure Medication
Timeline
| 6 Dec 2019 | Recall initiated by company | |
| 25 Dec 2019 | Published in enforcement report | +19 days |
| 27 Dec 2019 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Which lots are affected?
Lot #: 2190A, 2191A, Exp. Date 07/2021
Where was it sold?
Nationwide within the United States
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 III | Levetiracetam Tablets USP, 250 mg UD recalled by McKesson | McKesson | Other | 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 |