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Lupin Pharmaceuticals Inc.

7 ongoing recalls and 116 historical records

Based on the official records currently available to Public Health Trace, 7 recalls naming Lupin Pharmaceuticals Inc. are currently shown as ongoing. The other 116 records below are historical.

Public Health Trace has 123 recalls naming Lupin Pharmaceuticals Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall records - 123 total

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20181
201925
202019
202111
202214
20235
202414
20257
20264
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FDA Recall TerminatedTerminated: May 11, 2016Historical recordClass II

Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Published
January 22, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 30, 2013Historical recordClass III

Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Published
December 18, 2013
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 11, 2013Historical recordClass III

Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.

by Lupin Pharmaceuticals Inc.

Reason
Discoloration; Product may not meet specifications for color description once reconstituted.
Published
April 24, 2013
Distribution
Nationwide

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Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Lupin Pharmaceuticals Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.

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