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
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), 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
View recall →
FDA Recall
Terminated
Historical record Class II
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), 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
View recall →
FDA Recall
Terminated
Historical record Class II
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), 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
View recall →
FDA Recall
Terminated
Historical record Class II
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), 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
View recall →
FDA Recall
Terminated
Historical record Class II
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), 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
View recall →
FDA Recall
Terminated
Historical record Class III
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01 by Lupin Pharmaceuticals Inc.
Reason
Out-of-specification impurity test result observed at 18-month long term stability time point. Published
January 12, 2022 Distribution
Product Distributed in NY and OH.
View recall →
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
January 12, 2022 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class III
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13. by Lupin Pharmaceuticals Inc.
Reason
Subpotent Drug Published
December 8, 2021 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: impurity N-nitrosoirbesartan detected in API Published
November 10, 2021 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: impurity N-nitrosoirbesartan detected in API Published
November 10, 2021 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: impurity N-nitrosoirbesartan detected in API Published
November 10, 2021 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: impurity N-nitrosoirbesartan detected in API Published
November 10, 2021 Distribution
Nationwide
View recall →
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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