Skip to main content

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
Download CSV

FDA Recall TerminatedTerminated: January 30, 2023Historical recordClass 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 →

FDA Recall TerminatedTerminated: January 30, 2023Historical recordClass 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

View recall →

FDA Recall TerminatedTerminated: August 23, 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
November 3, 2021
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: March 13, 2023Historical recordClass 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

View recall →

FDA Recall TerminatedTerminated: February 22, 2022Historical recordClass 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

View recall →

FDA Recall TerminatedTerminated: December 16, 2021Historical recordClass 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

View recall →

FDA Recall TerminatedTerminated: December 16, 2021Historical recordClass 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

View recall →

FDA Recall TerminatedTerminated: January 21, 2022Historical recordClass 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

View recall →

FDA Recall TerminatedTerminated: August 26, 2021Historical recordClass 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…

View recall →

FDA Recall TerminatedTerminated: June 30, 2021Historical recordClass 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

View recall →

FDA Recall TerminatedTerminated: December 23, 2021Historical recordClass 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…

View recall →

FDA Recall TerminatedTerminated: December 23, 2021Historical recordClass 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…

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.

Reconnecting to the server…

We lost the connection to the server.

Your session has expired.