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
Year Recalls 2018 1 2019 25 2020 19 2021 11 2022 14 2023 5 2024 14 2025 7 2026 4
Download CSV FDA Recall
Terminated Terminated: December 23, 2021 Historical record Class II
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09 by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Published
July 22, 2020 Distribution
Product was distributed throughout the U…
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FDA Recall
Terminated Terminated: December 23, 2021 Historical record Class II
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01 by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Published
July 22, 2020 Distribution
Product was distributed throughout the U…
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FDA Recall
Terminated Terminated: December 23, 2021 Historical record Class II
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Published
July 1, 2020 Distribution
Product was distributed throughout the U…
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FDA Recall
Terminated Terminated: May 4, 2021 Historical record Class II
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03. by Lupin Pharmaceuticals Inc.
Reason
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. Published
June 17, 2020 Distribution
Nationwide
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FDA Recall
Terminated Terminated: June 7, 2021 Historical record Class II
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01 by Lupin Pharmaceuticals Inc.
Reason
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. Published
April 29, 2020 Distribution
Nationwide
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FDA Recall
Terminated Terminated: June 7, 2021 Historical record Class II
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 by Lupin Pharmaceuticals Inc.
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. Published
April 29, 2020 Distribution
Nationwide
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FDA Recall
Terminated Terminated: June 30, 2021 Historical record Class II
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01 by Lupin Pharmaceuticals Inc.
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. Published
April 8, 2020 Distribution
Nationwide
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FDA Recall
Terminated Terminated: May 25, 2021 Historical record Class II
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. by Lupin Pharmaceuticals Inc.
Reason
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. Published
March 18, 2020 Distribution
Nationwide
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FDA Recall
Terminated Terminated: May 25, 2021 Historical record Class III
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. by Lupin Pharmaceuticals Inc.
Reason
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity. Published
March 18, 2020 Distribution
Nationwide
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FDA Recall
Terminated Terminated: June 3, 2021 Historical record Class II
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specification; high out of specification results observed Published
March 11, 2020 Distribution
Product was distributed throughout the U…
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FDA Recall
Terminated Terminated: June 3, 2021 Historical record Class II
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06 by Lupin Pharmaceuticals Inc.
Reason
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study. Published
February 19, 2020 Distribution
Nationwide
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FDA Recall
Terminated Terminated: June 3, 2021 Historical record Class III
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet) by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data. Published
January 22, 2020 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 .
