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Recall Observatory FDA recall evidence

Drug product

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01

D-1079-2020

April 01, 2020

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 85355
Status
Terminated
Classification
Class II
Quantity
25,944 bottles
Official record key
drug-enforcement:D-1079-2020

Official wording

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 Lisinopril Tablets.

Code information: Lot #: Q900580, Exp 9/2021

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablet