DrugSep 2, 2026
Clobetasol Propionate Cream USP, 0.05%, 60 g tube recall — FDA D-0789-2026
Failed content uniformity specifications.
Class IIFDA: OngoingLupin Pharmaceuticals Inc.
Recall history in this database
Classification mix: Class II: 63, Class III: 35, Class I: 5.
DrugJul 8, 2026
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial recall — FDA D-0723-2026
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class IIFDA: OngoingLupin Pharmaceuticals Inc.
DrugMay 27, 2026
Liraglutide Injection, 18 mg/3 mL (6 mg/mL) recall — FDA D-0541-2026
Presence of particulate matter: a white thread-like structure in the cartridge
Class IIFDA: OngoingLupin Pharmaceuticals Inc.
DrugDec 17, 2025
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge recall — FDA D-0220-2026
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class IIFDA: OngoingLupin Pharmaceuticals Inc.
DrugAug 6, 2025
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle recall — FDA D-0542-2025
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 30, 2025
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay recall — FDA D-0537-2025
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at…
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 23, 2025
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles recall — FDA D-0532-2025
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet…
Class IIFDA: OngoingLupin Pharmaceuticals Inc.
DrugApr 30, 2025
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle recall — FDA D-0377-2025
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability…
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJan 8, 2025
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets recall — FDA D-0167-2025
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 27, 2024
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01) recall — FDA D-0054-2025
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 27, 2024
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC recall — FDA D-0052-2025
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugNov 27, 2024
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01) recall — FDA D-0053-2025
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugSep 4, 2024
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle recall — FDA D-0648-2024
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJun 5, 2024
Cefdinir for Oral Suspension USP, 250 mg/5 mL recall — FDA D-0518-2024
Defective container: lack of seal integrity.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 22, 2024
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle recall — FDA D-0496-2024
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugMay 22, 2024
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle recall — FDA D-0497-2024
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugFeb 28, 2024
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted recall — FDA D-0337-2024
Labeling: Incorrect or Missing Package Insert
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugFeb 7, 2024
Rifampin Capsules USP 150mg, 30-count bottle recall — FDA D-0283-2024
Subpotent Drug and Failed Impurities/Degradation Specifications
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugFeb 7, 2024
Rifampin Capsules USP 300mg, 30-count bottle recall — FDA D-0284-2024
Subpotent Drug and Failed Impurities/Degradation Specifications
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugAug 9, 2023
Tydemy recall — FDA D-1081-2023
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Class IFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJul 19, 2023
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles recall — FDA D-0899-2023
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugJan 18, 2023
Rifampin Capsules USP, 300 mg, 30-count bottle recall — FDA D-0100-2023
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugDec 28, 2022
Quinapril Tablets USP, 20 mg (90 pack) recall — FDA D-0089-2023
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugDec 28, 2022
Quinapril Tablets USP, 40 mg (90 pack) recall — FDA D-0088-2023
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
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.