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
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01 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
Terminated
Historical record Class II
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 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 1, 2020 Distribution
Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical record Class II
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03. by Lupin Pharmaceuticals Inc.
Reason
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. Published
June 17, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01 by Lupin Pharmaceuticals Inc.
Reason
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. Published
April 29, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03 by Lupin Pharmaceuticals Inc.
Reason
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles. Published
April 29, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01 by Lupin Pharmaceuticals Inc.
Reason
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets. Published
April 8, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. by Lupin Pharmaceuticals Inc.
Reason
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. Published
March 18, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class III
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. by Lupin Pharmaceuticals Inc.
Reason
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity. Published
March 18, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD by Lupin Pharmaceuticals Inc.
Reason
Failed Impurities/Degradation Specification; high out of specification results observed Published
March 11, 2020 Distribution
Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical record Class II
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06 by Lupin Pharmaceuticals Inc.
Reason
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study. Published
February 19, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class III
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet) by Lupin Pharmaceuticals Inc.
Reason
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data. Published
January 22, 2020 Distribution
Nationwide
View recall →
FDA Recall
Terminated
Historical record Class II
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11 by Lupin Pharmaceuticals Inc.
Reason
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack. Published
January 15, 2020 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.
Read the full medical disclaimer .
