LISINOPRIL

Generic: LISINOPRIL

Chartwell RXManufacturer

ORALRoute

LISINOPRILActive Substance

2020-09-15Original Approval

LISINOPRIL is FDA application ANDA212041, sponsored by SCIEGEN PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2023-10-27

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 061

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within

Class III2016-04-04

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose interm

Class II2020-07-17

Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laborator

Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of L

Class III2013-04-09

Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400

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

Class II2025-06-20

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle

Class II2019-07-19

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharma

Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg obs

Class II2022-09-13

Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

Class III2016-04-06

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose interm

Class II2022-01-26

Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin P

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Class II2020-04-01

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Mary

Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril

LISINOPRIL

Recalls

Top Reported Reactions