DrugSep 21, 2022
Lisinopril Tablets USP, 10 mg, 1000-count bottles recall — FDA D-1536-2022
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
Recall history in this database
Classification mix: Class II: 63, Class III: 35, Class I: 5.
DrugJun 22, 2022
Lupin Pharmaceuticals Zileuton Extended-Release Tablets, 600 mg, 120-count bottle recall — FDA D-1150-2022
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 11, 2022
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) recall — FDA D-0840-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 11, 2022
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) recall — FDA D-0839-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 11, 2022
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles recall — FDA D-0843-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 11, 2022
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles recall — FDA D-0842-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 11, 2022
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) recall — FDA D-0838-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 11, 2022
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles recall — FDA D-0841-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJan 12, 2022
Lupin Pharmaceuticals Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle recall — FDA D-0326-2022
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJan 12, 2022
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles recall — FDA D-0358-2022
Out-of-specification impurity test result observed at 18-month long term stability time point.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugDec 8, 2021
Lupin Pharmaceuticals Tydemy recall — FDA D-0264-2022
Subpotent Drug
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 10, 2021
Lupin Pharmaceuticals Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 recall — FDA D-0090-2022
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 10, 2021
Lupin Pharmaceuticals Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 recall — FDA D-0089-2022
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 3, 2021
Lupin Pharmaceuticals Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle recall — FDA D-0091-2022
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugOct 27, 2021
Imipramine Pamoate Capsules 125 mg, 30-count bottle recall — FDA D-0027-2022
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugApr 21, 2021
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles recall — FDA D-0332-2021
Superpotent Drug
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugFeb 10, 2021
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL recall — FDA D-0247-2021
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugAug 19, 2020
Lupin Pharmaceuticals Mibelas 24 Fe recall — FDA D-1502-2020
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugAug 5, 2020
Lisinopril Tablets USP, 10 mg, 1000 count bottles recall — FDA D-1413-2020
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 29, 2020
Cefdinir for Oral Suspension USP, 250 mg/5mL recall — FDA D-1406-2020
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles recall — FDA D-1382-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles recall — FDA D-1385-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles recall — FDA D-1384-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 22, 2020
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles recall — FDA D-1383-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Lupin Pharmaceuticals Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.