The Recall Desk
LowFDA (Drugs)·D-269-2013·Announced 2013-05-01

Mylan Recalls Lisinopril Tablets With Incorrect Identifier Codes

Mylan Pharmaceuticals is recalling 2,405 bottles of Lisinopril 10 mg tablets because the pills have the wrong ID code imprinted on them.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because the product is unlikely to cause adverse health consequences. The defect is a labeling/imprint error without reported harm.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 2,405 bottles of Lisinopril Tablets, USP 10 mg. The specific product affected is the 1000-count bottle with NDC 0378-20740-10, Lot # 3002450, and an expiration date of 8/14. The recall is due to the tablets being imprinted with an incorrect identifier code on the embossed surface.

The affected products were distributed nationwide. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.

Consumers with this specific lot of Lisinopril should stop using the medication and contact their healthcare provider or pharmacist for a replacement. The incorrect imprint may cause confusion regarding the medication's identity, though the recall notice does not report any illnesses or injuries associated with this defect.

The recalled product

Product
Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10
Affected units
2,405

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# 3002450
  • exp 8/14

Distribution

Distributed nationwide across the United States.