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Lupin Pharmaceuticals Recalls

122 recalls on record · April 24, 2013 to July 8, 2026 · Drugs

Recalls by year

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

July 22, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmac

Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

July 1, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceu

Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

June 17, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 2

Hazard: Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.

April 29, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 2

Hazard: Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

April 29, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21

Hazard: 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.

April 8, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Mary

Hazard: 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.

March 18, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wall

Hazard: Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.

March 18, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), pac

Hazard: Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.

March 11, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuti

Hazard: Failed Impurities/Degradation Specification; high out of specification results observed

February 19, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuti

Hazard: Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

January 22, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls 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

Hazard: CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

January 15, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only,

Hazard: Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

January 8, 2020DrugsFDA

Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupi

Hazard: Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

December 25, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-co

Hazard: Failed Dissolution Specifications: High out of specification result observed at stability studies.

November 13, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 6818

Hazard: Presence of Foreign substance: identified as a dead ant.

November 13, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Balt

Hazard: Presence of Foreign substance: identified as a dead ant.

November 13, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 11

Hazard: Presence of Foreign substance: identified as a dead ant.

August 21, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Ph

Hazard: Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

August 7, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets

Hazard: Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.

July 31, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharma

Hazard: Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.

July 31, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmac

Hazard: Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.

July 24, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupi

Hazard: Labeling: Missing label; Product complaints reported missing bottle label.

June 5, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin

Hazard: Complaint received of metal piece identified in the product bottle prior to the reconstitution.

April 17, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,

Hazard: Failed Impurities/Degradation Specifications; 18 month long term stability study.

April 3, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and eth

Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.

March 27, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor

Hazard: Defective Container: Repetitive complaints received indicating pump not working.

March 6, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 7

Hazard: Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

February 27, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx

Hazard: CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

February 20, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.

Hazard: Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

February 13, 2019DrugsFDA

Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles,

Hazard: Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.