Lupin Pharmaceuticals Inc.

51 FDA enforcement actions

51 Total Recalls

1 Class I

43 Class II

7 Class III

Firm Details

Product Types: drug
States: FL, MD

All Recalls

Class II: Risk 11/13/2025 drug

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II: Risk 11/05/2025 drug

Defective container - seal not adhering to bottles
Class II: Risk 07/02/2025 drug

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class II: Risk 06/27/2025 drug

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Class II: Risk 06/20/2025 drug

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 identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II: Risk 04/10/2025 drug

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Class II: Risk 12/20/2024 drug

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Class II: Risk 10/23/2024 drug

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II: Risk 10/23/2024 drug

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II: Risk 10/23/2024 drug

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II: Risk 08/21/2024 drug

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class II: Risk 05/30/2024 drug

Failed Content Uniformity Specifications
Class II: Risk 05/08/2024 drug

Defective container: lack of seal integrity.
Class II: Risk 04/24/2024 drug

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II: Risk 04/24/2024 drug

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II: Risk 03/21/2024 drug

Subpotent Drug
Class II: Risk 02/05/2024 drug

Labeling: Incorrect or Missing Package Insert
Class II: Risk 01/05/2024 drug

Subpotent Drug and Failed Impurities/Degradation Specifications
Class II: Risk 01/05/2024 drug

Subpotent Drug and Failed Impurities/Degradation Specifications
Class II: Risk 01/03/2024 drug

Failed Impurities/Degradation Specifications
Class II: Risk 12/20/2023 drug

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Class II: Risk 11/22/2023 drug

Failed Dissolution Specifications
Class III: Low Risk 06/27/2023 drug

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class I: Dangerous 06/23/2023 drug

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Class III: Low Risk 01/20/2023 drug

Subpotent Drug: Low assay result observed during long-term stability testing.
Class II: Risk 12/12/2022 drug

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Class II: Risk 12/07/2022 drug

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II: Risk 12/07/2022 drug

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II: Risk 09/13/2022 drug

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II: Risk 07/28/2022 drug

CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II: Risk 06/10/2022 drug

Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class II: Risk 04/27/2022 drug

Failed Stability Specification
Class II: Risk 03/31/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 03/31/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 03/31/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 03/31/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 03/31/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II: Risk 03/31/2022 drug

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class III: Low Risk 12/29/2021 drug

Out-of-specification impurity test result observed at 18-month long term stability time point.
Class III: Low Risk 12/22/2021 drug

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class III: Low Risk 11/19/2021 drug

Subpotent Drug
Class III: Low Risk 10/20/2021 drug

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class II: Risk 10/12/2021 drug

CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II: Risk 10/12/2021 drug

CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II: Risk 10/12/2021 drug

CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II: Risk 10/12/2021 drug

CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II: Risk 10/12/2021 drug

CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II: Risk 10/08/2021 drug

Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class II: Risk 04/29/2021 drug

Subpotent Drug
Class II: Risk 03/26/2021 drug

Superpotent Drug
Class III: Low Risk 01/21/2021 drug

Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.