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Lupin Pharmaceuticals Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20182
201925
202019
202111
202214
20235
202414
20257
20263
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FDA Recall Terminated Historical recordClass III

Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Published
January 8, 2020
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA

by Lupin Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Published
December 25, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign substance: identified as a dead ant.
Published
November 13, 2019
Distribution
Product was distributed to major distrib…

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FDA Recall Terminated Historical recordClass III

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign substance: identified as a dead ant.
Published
November 13, 2019
Distribution
Product was distributed to major distrib…

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FDA Recall Terminated Historical recordClass III

Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign substance: identified as a dead ant.
Published
November 13, 2019
Distribution
Product was distributed to major distrib…

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FDA Recall Terminated Historical recordClass II

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Published
August 21, 2019
Distribution
Product was distributed to wholesalers/d…

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FDA Recall Terminated Historical recordClass II

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Published
August 7, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Published
July 31, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01

by Lupin Pharmaceuticals Inc.

Reason
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Published
July 31, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.

by Lupin Pharmaceuticals Inc.

Reason
Labeling: Missing label; Product complaints reported missing bottle label.
Published
July 24, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20

by Lupin Pharmaceuticals Inc.

Reason
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Published
June 5, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Published
April 17, 2019
Distribution
Product was distributed to 6 wholesalers…

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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. Read the full medical disclaimer.