Is Lisinopril recalled?
41 FDA recalls mention Lisinopril. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lisinopril.
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…
Class II · Moderate risk Terminated Nov 15, 2024
Reason Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Class III · Low risk Terminated Oct 27, 2023
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class II · Moderate risk Terminated Sep 15, 2022
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk Terminated Sep 13, 2022
Reason Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk Terminated Jan 26, 2022
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated Jul 17, 2020
Reason Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class II · Moderate risk Terminated May 28, 2020
Reason Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Class II · Moderate risk Terminated Apr 20, 2020
Reason Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Class II · Moderate risk Terminated Apr 1, 2020
Reason 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…
Class II · Moderate risk Terminated Aug 5, 2019
Reason Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was…
Class II · Moderate risk Terminated Jul 19, 2019
Reason Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Class II · Moderate risk Terminated Jul 17, 2019
Reason Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed…
Class II · Moderate risk Terminated Aug 13, 2018
Reason Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class II · Moderate risk Terminated Dec 20, 2016
Reason Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class III · Low risk Terminated May 25, 2016
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated Apr 6, 2016
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated Apr 6, 2016
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated Apr 4, 2016
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class II · Moderate risk Terminated Jul 29, 2015
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated Jul 29, 2015
Reason CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk Terminated Jul 29, 2015
Reason CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk Terminated Jun 1, 2015
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated Jun 1, 2015
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated Jun 1, 2015
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.