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Recall Observatory FDA recall evidence

Drug product

Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03

D-1250-2020

April 20, 2020

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 85511
Status
Terminated
Classification
Class II
Quantity
11,808 bottles
Official record key
drug-enforcement:D-1250-2020

Official wording

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.

Code information: Lot # Q000255, Exp 01/2022

Distribution pattern: Product was distributed Nationwide in the United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.