SUN PHARMACEUTICAL INDUSTRIES INC

84 FDA enforcement actions

84 Total Recalls

0 Class I

59 Class II

24 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class III: Low Risk 01/27/2026 drug

This market withdrawal has been initiated in response to Out of Specification (OOS) results observed in in viscosity for Diclofenac Sodium Gel, 3%.
Class III: Low Risk 12/30/2025 drug

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class III: Low Risk 11/26/2025 drug

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class II: Risk 10/28/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 10/28/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II: Risk 09/03/2025 drug

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class II: Risk 08/05/2025 drug

Presence of foreign substance: identified as aluminum.
Class II: Risk 06/16/2025 drug

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Class III: Low Risk 03/04/2025 drug

Cross Contamination
Class III: Low Risk 03/04/2025 drug

Cross Contamination
Class II: Risk 02/06/2025 drug

Failed Dissolution Specifications
Class II: Risk 07/09/2024 drug

Failed Dissolution Specifications
Class II: Risk 07/02/2024 drug

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class III: Low Risk 04/22/2024 drug

Failed Release Testing: Out of specification for particulate matter test.
Class II: Risk 04/19/2024 drug

Out of specification for assay
Class II: Risk 03/04/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 03/04/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 02/05/2024 drug

Failed Dissolution Specifications: Out of specification for dissolution.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 01/18/2024 drug

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II: Risk 12/04/2023 drug

Failed Impurities/Degradation Specifications
Class III: Low Risk 11/22/2023 drug

Failed Dissolution Specifications
Class II: Risk 10/20/2023 drug

Failed Impurities/Degradation Specifications.
Class II: Risk 10/20/2023 drug

Failed Impurities/Degradation Specifications.
Class III: Low Risk 10/04/2023 drug

Failed Dissolution Specifications
Class III: Low Risk 09/07/2023 drug

Subpotent: Out of Specification result observed for low assay
Class III: Low Risk 07/18/2023 drug

Out of Specification result observed in content uniformity testing
Class II: Risk 07/13/2023 drug

Presence of Foreign Substance: Metal embedded in a tablet.
Class II: Risk 07/10/2023 drug

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class III: Low Risk 07/05/2023 drug

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class II: Risk 05/30/2023 drug

Subpotent drug
Class II: Risk 05/09/2023 drug

Failed Dissolution Specifications; during stability testing
Class II: Risk 05/03/2023 drug

CGMP Deviations
Class III: Low Risk 03/29/2023 drug

Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class III: Low Risk 03/09/2023 drug

Failed Content Uniformity Specifications
Class II: Risk 01/13/2023 drug

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Class II: Risk 12/01/2022 drug

Presence of foreign substance
Class II: Risk 10/18/2022 drug

Presence of Foreign Substance
Class II: Risk 07/25/2022 drug

Discoloration
Class II: Risk 06/27/2022 drug

Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class III: Low Risk 06/21/2022 drug

Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class II: Risk 06/21/2022 drug

cGMP - Water leakage
Class III: Low Risk 06/21/2022 drug

Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class II: Risk 06/10/2022 drug

Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Class II: Risk 06/03/2022 drug

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Class II: Risk 06/03/2022 drug

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Class II: Risk 06/03/2022 drug

Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class II: Risk 05/06/2022 drug

Lack of assurance of sterility
Class II: Risk 05/06/2022 drug

Lack of assurance of sterility
Class II: Risk 05/06/2022 drug

Lack of assurance of sterility
Class II: Risk 05/06/2022 drug

Lack of assurance of sterility
Class II: Risk 05/06/2022 drug

Lack of assurance of sterility
Class III: Low Risk 04/29/2022 drug

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III: Low Risk 04/29/2022 drug

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III: Low Risk 04/01/2022 drug

Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class II: Risk 02/07/2022 drug

Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Class II: Risk 10/25/2021 drug

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II: Risk 10/25/2021 drug

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Class II: Risk 10/22/2021 drug

Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Class III: Low Risk 10/12/2021 drug

Failed Moisture Limits
Class III: Low Risk 10/12/2021 drug

Failed Moisture Limits
Class II: Risk 07/29/2021 drug

Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Class III: Low Risk 05/07/2021 drug

Subpotent and Presence of Particulates .
Class II: Risk 05/04/2021 drug

Presence of foreign substance: identified as activated carbon.
Class II: Risk 03/31/2021 drug

Microbial Contamination of Non-Sterile Product
Class III: Low Risk 03/25/2021 drug

Failed Moisture Limits: Out of specification for water content
Class II: Risk 03/15/2021 drug

Failed Impurities/Degradation Specifications
Class III: Low Risk 02/22/2021 drug

Subpotent
Class III: Low Risk 02/05/2021 drug

Failed Impurity/Degradation Specifications
Class III: Low Risk 01/11/2021 drug

Incorrect Labeling: Incorrect lot number on secondary packaging

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.