Lupin Pharmaceuticals Inc. Recalls Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2018 2 2019 25 2020 19 2021 11 2022 14 2023 5 2024 14 2025 7 2026 3
Download CSV FDA Recall
Terminated
Historical record Class II
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01 by Lupin Pharmaceuticals Inc.
Reason
Failed Dissolution Specifications Published
December 20, 2023 Distribution
Product was distributed to 3 wholesale/d…
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FDA Recall
Terminated
Historical record Class I
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA by Lupin Pharmaceuticals Inc.
Reason
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test Published
August 9, 2023 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03 by Lupin Pharmaceuticals Inc.
Reason
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. Published
July 19, 2023 Distribution
Product was distributed directly to thre…
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FDA Recall
Terminated
Historical record Class III
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03 by Lupin Pharmaceuticals Inc.
Reason
Subpotent Drug: Low assay result observed during long-term stability testing. Published
February 1, 2023 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06 by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study. Published
January 18, 2023 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09 by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Published
December 28, 2022 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09 by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Published
December 28, 2022 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03 by Lupin Pharmaceuticals Inc.
Reason
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. Published
September 21, 2022 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06 by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. Published
August 24, 2022 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16 by Lupin Pharmaceuticals Inc.
Reason
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study. Published
June 22, 2022 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19 by Lupin Pharmaceuticals Inc.
Reason
Failed Stability Specification Published
May 25, 2022 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Published
May 11, 2022 Distribution
Nationwide
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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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