FDAClass IIIJune 22, 2016

Lisinopril Tablets USP recall: Labeling Error

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01

Why was Lisinopril Tablets USP recalled?

Labeling: Incorrect or Missing Package Insert

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # FC1960; Exp.: 02/18

Product
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
Recalling firm
Sandoz Inc
Quantity
3,048 bottles ( 304,800 tablets)
Distribution
Nationwide
Recall date
June 22, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls