Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
WHO, and other public sources. It is an independent information service, not a medical provider, and
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Policy version 2026-07-21, effective July 21, 2026.
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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.
FDA RecallTerminatedTerminated: October 19, 2020Historical recordClass III
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
FDA RecallTerminatedTerminated: September 14, 2020Historical recordClass II
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01
by Lupin Pharmaceuticals Inc.
Reason
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
FDA RecallTerminatedTerminated: September 14, 2020Historical recordClass III
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
by Lupin Pharmaceuticals Inc.
Reason
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
FDA RecallTerminatedTerminated: September 9, 2020Historical recordClass III
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
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.
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