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Class III: unlikely to cause harmTerminated

Aurobindo Pharma Lisinopril Tablets Recall

Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets

Aurobindo Pharma USA Inc · Plainsboro, NJ

Risk level
Class III
Reported by FDA
Jun 5, 2013
Recall ID
D-498-2013
Check your lot numberHow we source this data

Summary

Aurobindo Pharma recalled Lisinopril Tablets starting Apr 9, 2013. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-498-2013 on Jun 5, 2013. Reason: Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label. Status: Terminated.

Why it was recalled

Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label

Product description

Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-498-2013
Classification
Class III
Status
Terminated
Recall initiated
Apr 9, 2013
FDA report date
Jun 5, 2013
Quantity
1776 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Aurobindo Pharma USA Inc

Original FDA data

Every field from FDA enforcement report D-498-2013, exactly as published.

Show all FDA fields
City
Plainsboro
State
NJ
Status
Terminated
Country
United States
Event ID
65071
Address
666 Plainsboro Rd. Suite 210
Code information
Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
Postal code
08536-3004
Report date
Jun 5, 2013
Product type
Drugs
Recall number
D-498-2013
Classification
Class III
Recalling firm
Aurobindo Pharma USA Inc
Product quantity
1776 bottles
Termination date
Jan 23, 2014
Reason for recall
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Distribution pattern
Nationwide
Recall initiation date
Apr 9, 2013
Initial firm notification
Letter
Center classification date
May 30, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-498-2013, published Jun 5, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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