The Recall Desk
SevereFDA (Drugs)·D-1702-2012·Announced 2012-10-03

Mylan Recalls Levetiracetam Tablets Due to Foreign Tablet Presence

Mylan Pharmaceuticals is recalling 960 bottles of Levetiracetam 500 mg tablets because foreign tablets may have been distributed in the bottles.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury/property-damage reports or high-risk scenarios.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 960 bottles of Levetiracetam Tablets, USP 500 mg. The recall was initiated because the manufacturer may have distributed foreign tablets in bottles of the medication.

The affected product is identified by Lot ZLMM12063 with an expiration date of March 2014. The product was distributed to Kentucky. This is a prescription-only medication manufactured for Mylan Pharmaceuticals Inc. in Morgantown, WV.

Consumers who have this specific lot of Levetiracetam should stop using it and contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement.

The recalled product

Product
LEVETIRACETAM (LEVETIRACETAM)
Brand
LEVETIRACETAM
Affected units
960

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 ZLMM12063
  • Exp March 2014

Distribution

Distributed in 1 state: