Lisinopril And Hydrochlorothiazide Tablet
FDA Recall NDC 68180-520
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Lisinopril And Hydrochlorothiazide (NDC 68180-520). A significant event, classified as Class II, was initiated on Jun 20, 2025 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Jun 20, 2025
Jul 23, 2025
58,968 bottles
Recall Profile & Regulatory Data
Event ID
97118
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States.
Product Description
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Batch or Lot Expiration Information
Lot# : QA01081, Exp. Date April 2027
Affected Packages Involved in this Recall
68180-518-02Product
68180-518-01Product
68180-518-30Product
68180-519-30Product
68180-519-01Product
68180-519-02Product
68180-520-02Product
68180-520-30Product
68180-520-01Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
2 units
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
Batch or Lot Expiration Information
Batch# Batch Q101699, Q101981
Affected Packages Involved in this Recall
68180-518-02Product
68180-518-01Product
68180-518-30Product
68180-519-30Product
68180-519-01Product
68180-519-02Product
68180-520-02Product
68180-520-30Product
68180-520-01Product
Class II Terminated
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Jul 19, 2019
Jul 31, 2019
11,832 bottles
Recall Profile & Regulatory Data
Event ID
83363
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 09, 2020
Product Description
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02
Batch or Lot Expiration Information
Lot# :H801815, Exp. March 2021
Affected Packages Involved in this Recall
68180-518-02Product
68180-518-01Product
68180-518-30Product
68180-519-30Product
68180-519-01Product
68180-519-02Product
68180-520-02Product
68180-520-30Product
68180-520-01Product
July 2019 Class II Recall: Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Recall Number
Class II Terminated
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Jul 17, 2019
Aug 21, 2019
39,216 bottles
Recall Profile & Regulatory Data
Event ID
83354
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
Termination Date
Sep 14, 2020
Product Description
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01
Batch or Lot Expiration Information
Batch# H900575, exp. date 01/2022
Affected Packages Involved in this Recall
68180-518-02Product
68180-518-01Product
68180-518-30Product
68180-519-30Product
68180-519-01Product
68180-519-02Product
68180-520-02Product
68180-520-30Product
68180-520-01Product
Class III Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Apr 04, 2016
Jul 06, 2016
59,520 Bottles
Recall Profile & Regulatory Data
Event ID
73848
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 01, 2017
Product Description
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Batch or Lot Expiration Information
Lot# : a) H303459, b) H303460, Exp 09/2016
Affected Packages Involved in this Recall
68180-518-02Product
68180-518-01Product
68180-518-30Product
68180-519-30Product
68180-519-01Product
68180-519-02Product
68180-520-02Product
68180-520-30Product
68180-520-01Product
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.
