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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
YearRecalls
20181
201925
202019
202111
202214
20235
202414
20257
20264
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FDA Recall TerminatedTerminated: May 22, 2023Historical recordClass 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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FDA Recall TerminatedTerminated: May 22, 2023Historical recordClass 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 TerminatedTerminated: May 22, 2023Historical recordClass 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 TerminatedTerminated: May 22, 2023Historical recordClass 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 TerminatedTerminated: May 22, 2023Historical recordClass 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 TerminatedTerminated: May 22, 2023Historical recordClass 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 TerminatedTerminated: August 23, 2022Historical recordClass 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.

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FDA Recall TerminatedTerminated: September 12, 2022Historical recordClass 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

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FDA Recall TerminatedTerminated: November 15, 2022Historical recordClass 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

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FDA Recall TerminatedTerminated: January 30, 2023Historical recordClass 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

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FDA Recall TerminatedTerminated: January 30, 2023Historical recordClass 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 TerminatedTerminated: January 30, 2023Historical recordClass 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 →

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.

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