Aurobindo Pharma USA Inc

20 FDA enforcement actions

20 Total Recalls

1 Class I

17 Class II

2 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 05/22/2025 drug

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II: Risk 12/06/2024 drug

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II: Risk 11/07/2024 drug

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024 drug

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 11/07/2024 drug

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class I: Dangerous 07/11/2024 drug

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class II: Risk 04/24/2024 drug

Discoloration: Dotted and yellow spots on tablets
Class II: Risk 04/24/2024 drug

Discoloration: Dotted and yellow spots on tablets
Class II: Risk 08/02/2023 drug

Failed dissolution specifications - results obtained were below spec average.
Class II: Risk 07/21/2023 drug

cGMP deviations: Batch was released prior to approval.
Class II: Risk 07/21/2023 drug

cGMP deviations: Batch was released prior to approval.
Class II: Risk 05/22/2023 drug

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Class II: Risk 10/05/2022 drug

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class III: Low Risk 04/05/2022 drug

Subpotent Drug: Out of Specification results for Assay
Class II: Risk 01/14/2022 drug

Failed Impurities/Degradation Specifications
Class II: Risk 12/29/2021 drug

Superpotent and Failed Tablet/Capsule Specifications
Class III: Low Risk 11/15/2021 drug

Failed Impurities/Degradation Specifications
Class II: Risk 09/09/2021 drug

Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Class II: Risk 07/07/2021 drug

Presence of Foreign Substance- Potential of metal contamination.
Class II: Risk 01/20/2021 drug

Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.

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.