Lisinopril Tablet
FDA Recall NDC 68180-982

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 6 recorded enforcement report(s) associated with Lisinopril (NDC 68180-982). A significant event, classified as Class II, was initiated on Sep 13, 2022 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet."

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-1536-2022TERMINATEDD-1290-2020TERMINATEDD-1079-2020TERMINATEDD-1077-2018TERMINATEDD-1503-2016TERMINATEDD-1502-2016TERMINATED

September 2022 Class II Recall: Presence of Foreign Substance

Recall Number
D-1536-2022
Class II Terminated
Reason for Recall
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Initiated
Sep 13, 2022
Reported
Sep 21, 2022
Quantity
11,802 1000-count bottles

Recall Profile & Regulatory Data

Event ID
90859
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors/wholesalers nationwide.
Termination Date
Jan 31, 2024
Product Description
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Batch or Lot Expiration Information
Lot# Q201182, exp. date March 2024
Affected Packages Involved in this Recall
68180-512-02Product
68180-512-30Product
68180-512-09Product
68180-512-01Product
68180-512-03Product
68180-513-30Product
68180-513-03Product
68180-513-01Product
68180-513-09Product
68180-513-02Product
68180-513-05Product
68180-517-03Product
68180-517-01Product
68180-517-30Product
68180-517-09Product
68180-517-04Product
68180-517-02Product
68180-980-03Product
68180-980-30Product
68180-980-01Product
68180-980-09Product
68180-980-05Product
68180-980-02Product
68180-981-01Product
68180-981-03Product
68180-981-30Product
68180-981-09Product
68180-981-02Product
68180-981-05Product
68180-982-01Product
68180-982-02Product
68180-982-30Product
68180-982-03Product
68180-982-09Product
68180-979-01Product
68180-979-03Product
68180-979-30Product
68180-979-09Product
68180-514-01Product
68180-514-02Product
68180-514-03Product
68180-514-09Product
68180-514-30Product
68180-514-05Product
68180-515-01Product
68180-515-02Product
68180-515-03Product
68180-515-09Product
68180-515-30Product
68180-515-05Product
68180-516-01Product
68180-516-02Product
68180-516-03Product
68180-516-09Product
68180-516-30Product

May 2020 Class II Recall: Product Mix Up

Recall Number
D-1290-2020
Class II Terminated
Reason for Recall
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Initiated
May 28, 2020
Reported
Jun 17, 2020
Quantity
4,224 bottles

Recall Profile & Regulatory Data

Event ID
85770
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US.
Termination Date
May 04, 2021
Product Description
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
Batch or Lot Expiration Information
Lot# Q900683, Exp. 10/31/2022
Affected Packages Involved in this Recall
68180-512-02Product
68180-512-30Product
68180-512-09Product
68180-512-01Product
68180-512-03Product
68180-513-30Product
68180-513-03Product
68180-513-01Product
68180-513-09Product
68180-513-02Product
68180-513-05Product
68180-517-03Product
68180-517-01Product
68180-517-30Product
68180-517-09Product
68180-517-04Product
68180-517-02Product
68180-980-03Product
68180-980-30Product
68180-980-01Product
68180-980-09Product
68180-980-05Product
68180-980-02Product
68180-981-01Product
68180-981-03Product
68180-981-30Product
68180-981-09Product
68180-981-02Product
68180-981-05Product
68180-982-01Product
68180-982-02Product
68180-982-30Product
68180-982-03Product
68180-982-09Product
68180-979-01Product
68180-979-03Product
68180-979-30Product
68180-979-09Product
68180-514-01Product
68180-514-02Product
68180-514-03Product
68180-514-09Product
68180-514-30Product
68180-514-05Product
68180-515-01Product
68180-515-02Product
68180-515-03Product
68180-515-09Product
68180-515-30Product
68180-515-05Product
68180-516-01Product
68180-516-02Product
68180-516-03Product
68180-516-09Product
68180-516-30Product

April 2020 Class II Recall: Presence of Foreign Tablet/ Capsule

Recall Number
D-1079-2020
Class II Terminated
Reason for Recall
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Initiated
Apr 01, 2020
Reported
Apr 08, 2020
Quantity
25,944 bottles

Recall Profile & Regulatory Data

Event ID
85355
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Jun 30, 2021
Product Description
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
Batch or Lot Expiration Information
Lot# : Q900580, Exp 9/2021
Affected Packages Involved in this Recall
68180-512-02Product
68180-512-30Product
68180-512-09Product
68180-512-01Product
68180-512-03Product
68180-513-30Product
68180-513-03Product
68180-513-01Product
68180-513-09Product
68180-513-02Product
68180-513-05Product
68180-517-03Product
68180-517-01Product
68180-517-30Product
68180-517-09Product
68180-517-04Product
68180-517-02Product
68180-980-03Product
68180-980-30Product
68180-980-01Product
68180-980-09Product
68180-980-05Product
68180-980-02Product
68180-981-01Product
68180-981-03Product
68180-981-30Product
68180-981-09Product
68180-981-02Product
68180-981-05Product
68180-982-01Product
68180-982-02Product
68180-982-30Product
68180-982-03Product
68180-982-09Product
68180-979-01Product
68180-979-03Product
68180-979-30Product
68180-979-09Product
68180-514-01Product
68180-514-02Product
68180-514-03Product
68180-514-09Product
68180-514-30Product
68180-514-05Product
68180-515-01Product
68180-515-02Product
68180-515-03Product
68180-515-09Product
68180-515-30Product
68180-515-05Product
68180-516-01Product
68180-516-02Product
68180-516-03Product
68180-516-09Product
68180-516-30Product

August 2018 Class II Recall: Presence of Foreign Substance

Recall Number
D-1077-2018
Class II Terminated
Reason for Recall
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Initiated
Aug 13, 2018
Reported
Aug 22, 2018
Quantity
11,706 bottles

Recall Profile & Regulatory Data

Event ID
80789
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
Termination Date
Oct 15, 2019
Product Description
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
Batch or Lot Expiration Information
Lot# : H800414, Exp. 12/2019
Affected Packages Involved in this Recall
68180-512-02Product
68180-512-30Product
68180-512-09Product
68180-512-01Product
68180-512-03Product
68180-513-30Product
68180-513-03Product
68180-513-01Product
68180-513-09Product
68180-513-02Product
68180-513-05Product
68180-517-03Product
68180-517-01Product
68180-517-30Product
68180-517-09Product
68180-517-04Product
68180-517-02Product
68180-980-03Product
68180-980-30Product
68180-980-01Product
68180-980-09Product
68180-980-05Product
68180-980-02Product
68180-981-01Product
68180-981-03Product
68180-981-30Product
68180-981-09Product
68180-981-02Product
68180-981-05Product
68180-982-01Product
68180-982-02Product
68180-982-30Product
68180-982-03Product
68180-982-09Product
68180-979-01Product
68180-979-03Product
68180-979-30Product
68180-979-09Product
68180-514-01Product
68180-514-02Product
68180-514-03Product
68180-514-09Product
68180-514-30Product
68180-514-05Product
68180-515-01Product
68180-515-02Product
68180-515-03Product
68180-515-09Product
68180-515-30Product
68180-515-05Product
68180-516-01Product
68180-516-02Product
68180-516-03Product
68180-516-09Product
68180-516-30Product

April 2016 Class III Recall: CGMP Deviations

Recall Number
D-1503-2016
Class III Terminated
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Initiated
Apr 06, 2016
Reported
Sep 28, 2016
Quantity
5,880 bottles

Recall Profile & Regulatory Data

Event ID
74945
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
Termination Date
Aug 07, 2017
Product Description
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.
Batch or Lot Expiration Information
Batch# Batch number: H303449, Exp 09/16
Affected Packages Involved in this Recall
68180-512-02Product
68180-512-30Product
68180-512-09Product
68180-512-01Product
68180-512-03Product
68180-513-30Product
68180-513-03Product
68180-513-01Product
68180-513-09Product
68180-513-02Product
68180-513-05Product
68180-517-03Product
68180-517-01Product
68180-517-30Product
68180-517-09Product
68180-517-04Product
68180-517-02Product
68180-980-03Product
68180-980-30Product
68180-980-01Product
68180-980-09Product
68180-980-05Product
68180-980-02Product
68180-981-01Product
68180-981-03Product
68180-981-30Product
68180-981-09Product
68180-981-02Product
68180-981-05Product
68180-982-01Product
68180-982-02Product
68180-982-30Product
68180-982-03Product
68180-982-09Product
68180-979-01Product
68180-979-03Product
68180-979-30Product
68180-979-09Product
68180-514-01Product
68180-514-02Product
68180-514-03Product
68180-514-09Product
68180-514-30Product
68180-514-05Product
68180-515-01Product
68180-515-02Product
68180-515-03Product
68180-515-09Product
68180-515-30Product
68180-515-05Product
68180-516-01Product
68180-516-02Product
68180-516-03Product
68180-516-09Product
68180-516-30Product

April 2016 Class III Recall: CGMP Deviations

Recall Number
D-1502-2016
Class III Terminated
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Initiated
Apr 06, 2016
Reported
Sep 28, 2016
Quantity
20,556 bottles

Recall Profile & Regulatory Data

Event ID
74945
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
Termination Date
Aug 07, 2017
Product Description
Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
Batch or Lot Expiration Information
Batch# Batch number: H303487, H303488, H303489, Exp 09/16
Affected Packages Involved in this Recall
68180-512-02Product
68180-512-30Product
68180-512-09Product
68180-512-01Product
68180-512-03Product
68180-513-30Product
68180-513-03Product
68180-513-01Product
68180-513-09Product
68180-513-02Product
68180-513-05Product
68180-517-03Product
68180-517-01Product
68180-517-30Product
68180-517-09Product
68180-517-04Product
68180-517-02Product
68180-980-03Product
68180-980-30Product
68180-980-01Product
68180-980-09Product
68180-980-05Product
68180-980-02Product
68180-981-01Product
68180-981-03Product
68180-981-30Product
68180-981-09Product
68180-981-02Product
68180-981-05Product
68180-982-01Product
68180-982-02Product
68180-982-30Product
68180-982-03Product
68180-982-09Product
68180-979-01Product
68180-979-03Product
68180-979-30Product
68180-979-09Product
68180-514-01Product
68180-514-02Product
68180-514-03Product
68180-514-09Product
68180-514-30Product
68180-514-05Product
68180-515-01Product
68180-515-02Product
68180-515-03Product
68180-515-09Product
68180-515-30Product
68180-515-05Product
68180-516-01Product
68180-516-02Product
68180-516-03Product
68180-516-09Product
68180-516-30Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.