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
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: impurity N-nitrosoirbesartan detected in API Published
November 10, 2021 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. by Lupin Pharmaceuticals Inc.
Reason
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. Published
November 3, 2021 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06 by Lupin Pharmaceuticals Inc.
Reason
Out of specification result observed in a dissolution test at the 9-month long term stability time point. Published
October 27, 2021 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01 by Lupin Pharmaceuticals Inc.
Reason
Subpotent Drug Published
May 26, 2021 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India. by Lupin Pharmaceuticals Inc.
Reason
Superpotent Drug Published
April 21, 2021 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01 by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point. Published
February 10, 2021 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India. by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test. Published
August 19, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08 by Lupin Pharmaceuticals Inc.
Reason
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg Published
August 5, 2020 Distribution
Product was distributed to OH and may ha…
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FDA Recall
Terminated
Historical record Class II
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20 by Lupin Pharmaceuticals Inc.
Reason
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. Published
July 29, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07 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
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 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 22, 2020 Distribution
Product was distributed throughout the U…
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FDA Recall
Terminated
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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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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