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Lisinopril

FDA recalls

8 rows

DateCompany and reasonClass
Nov 14, 2024Evaric Pharmaceuticals Inc.
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.		Class II · Terminated
Oct 26, 2023Ncs Healthcare of Kentucky Inc
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots		Class III · Terminated
Sep 12, 2022Lupin Pharmaceuticals Inc.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.		Class II · Terminated
May 27, 2020Lupin Pharmaceuticals Inc.
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.		Class II · Terminated
Mar 31, 2020Lupin Pharmaceuticals Inc.
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.		Class II · Terminated
Aug 12, 2018Lupin Pharmaceuticals Inc.
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.		Class II · Terminated
Apr 5, 2016Lupin Pharmaceuticals Inc.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.		Class III · Terminated
Apr 8, 2013Aurobindo Pharma USA Inc
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label		Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).