Agency classClass IIIOur severity:Low FDA (Drugs)·D-498-2013·Announced 2013-06-05

Aurobindo Recalls Lisinopril Tablets Due to Labeling Error

Aurobindo Pharma USA Inc is recalling specific lots of Lisinopril 30 mg tablets because the label displays the incorrect strength on the side panel.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the displayed strength, which falls under the 'Low' severity criteria for cosmetic or documentation issues.

Plain-English summary

Aurobindo Pharma USA Inc is recalling 1,776 bottles of Lisinopril Tablets, USP, 30 mg. The recall is due to a labeling error where the side display panel of the label lists an incorrect strength. The affected product is a prescription-only medication manufactured by Aurobindo Pharma Limited in India and distributed nationwide.

The recall involves two specific lots: Lot KP3012001-A and Lot KP3012002-A, both with an expiration date of 12/13. The product is identified by NDC 65862-041-01. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this medication should check the lot number and expiration date on their bottles. If the product matches the recalled lots, they should contact their pharmacist or healthcare provider for guidance on how to proceed.

The recalled product

Product: LISINOPRIL (LISINOPRIL)
Brand: LISINOPRIL
Manufacturer: Aurobindo Pharma USA Inc
Category: Drug — Prescription Drug
Hazard: mis-labeling
Affected units: 1,776

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 KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13

UPCs (3)

0365862037015
0365862038012
0365862040015

Distribution

Distributed nationwide across the United States.

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Same hazard · mis labeling