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Lupin Pharmaceuticals Recalls
122 recalls on record · April 24, 2013 to July 8, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 28, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Hazard: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
September 21, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar
Hazard: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
August 24, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore,
Hazard: CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
June 22, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Balt
Hazard: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
May 25, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-1
Hazard: Failed Stability Specification
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-c
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-cou
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-co
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-0
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-0
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
January 12, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Hazard: Out-of-specification impurity test result observed at 18-month long term stability time point.
January 12, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Hazard: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
December 8, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium t
Hazard: Subpotent Drug
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-4
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-4
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Hazard: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
November 3, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Hazard: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
October 27, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Ma
Hazard: Out of specification result observed in a dissolution test at the 9-month long term stability time point.
May 26, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Ba
Hazard: Subpotent Drug
April 21, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (wh
Hazard: Superpotent Drug
February 10, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:
Hazard: Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
August 19, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/7
Hazard: Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
August 5, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laborator
Hazard: Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
July 29, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceutical
Hazard: Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
July 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmac
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmace
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
July 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmac
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level