https://plainrecords.com/brand/sun-pharmaceutical-industries/New recalls of Sun Pharmaceutical Industries from FDA, CPSC and NHTSA records.en-ushttps://plainrecords.com/recall/drug/n-a-99876-0ce17c/https://plainrecords.com/recall/drug/n-a-99876-0ce17c/Wed, 23 Sep 2026 00:00:00 +0000Failed Stability Specificationshttps://plainrecords.com/recall/drug/d-0770-2026/https://plainrecords.com/recall/drug/d-0770-2026/Wed, 26 Aug 2026 00:00:00 +0000CGMP Deviations; black spots found on tablets from burnt excipient during manufacturinghttps://plainrecords.com/recall/drug/d-0654-2026/https://plainrecords.com/recall/drug/d-0654-2026/Wed, 08 Jul 2026 00:00:00 +0000Failed Impurities/Degradation Specificationshttps://plainrecords.com/recall/drug/d-0628-2026/https://plainrecords.com/recall/drug/d-0628-2026/Wed, 01 Jul 2026 00:00:00 +0000Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.https://plainrecords.com/recall/drug/d-0607-2026/https://plainrecords.com/recall/drug/d-0607-2026/Wed, 17 Jun 2026 00:00:00 +0000Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solutionhttps://plainrecords.com/recall/drug/d-0580-2026/https://plainrecords.com/recall/drug/d-0580-2026/Wed, 17 Jun 2026 00:00:00 +0000Presence of Particulate matter: Particulate matter identified as glass.https://plainrecords.com/recall/drug/d-0598-2026/https://plainrecords.com/recall/drug/d-0598-2026/Wed, 10 Jun 2026 00:00:00 +0000Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvonahttps://plainrecords.com/recall/fda/sun-pharmaceutical-industries-inc-sun-pharma-initiates-voluntary-us-nationwide-recall-doxorubicin/https://plainrecords.com/recall/fda/sun-pharmaceutical-industries-inc-sun-pharma-initiates-voluntary-us-nationwide-recall-doxorubicin/Wed, 13 May 2026 00:00:00 +0000Presence of glass particleshttps://plainrecords.com/recall/drug/d-0475-2026/https://plainrecords.com/recall/drug/d-0475-2026/Wed, 22 Apr 2026 00:00:00 +0000Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.https://plainrecords.com/recall/drug/d-0342-2026/https://plainrecords.com/recall/drug/d-0342-2026/Wed, 11 Feb 2026 00:00:00 +0000Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.https://plainrecords.com/recall/drug/d-0257-2026/https://plainrecords.com/recall/drug/d-0257-2026/Wed, 21 Jan 2026 00:00:00 +0000Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.https://plainrecords.com/recall/drug/d-0256-2026/https://plainrecords.com/recall/drug/d-0256-2026/Wed, 21 Jan 2026 00:00:00 +0000Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.https://plainrecords.com/recall/drug/d-0144-2026/https://plainrecords.com/recall/drug/d-0144-2026/Wed, 05 Nov 2025 00:00:00 +0000Failed 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.https://plainrecords.com/recall/drug/d-0658-2025/https://plainrecords.com/recall/drug/d-0658-2025/Wed, 24 Sep 2025 00:00:00 +0000Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.https://plainrecords.com/recall/drug/d-0574-2025/https://plainrecords.com/recall/drug/d-0574-2025/Wed, 13 Aug 2025 00:00:00 +0000Presence of foreign substance: identified as aluminum.https://plainrecords.com/recall/drug/d-0516-2025/https://plainrecords.com/recall/drug/d-0516-2025/Wed, 23 Jul 2025 00:00:00 +0000Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).https://plainrecords.com/recall/drug/d-0311-2025/https://plainrecords.com/recall/drug/d-0311-2025/Wed, 16 Apr 2025 00:00:00 +0000Cross Contaminationhttps://plainrecords.com/recall/drug/d-0249-2025/https://plainrecords.com/recall/drug/d-0249-2025/Wed, 12 Mar 2025 00:00:00 +0000Failed Dissolution Specificationshttps://plainrecords.com/recall/drug/d-0597-2024/https://plainrecords.com/recall/drug/d-0597-2024/Wed, 24 Jul 2024 00:00:00 +0000Failed Dissolution Specificationshttps://plainrecords.com/recall/drug/d-0582-2024/https://plainrecords.com/recall/drug/d-0582-2024/Wed, 10 Jul 2024 00:00:00 +0000CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.https://plainrecords.com/recall/drug/d-0502-2024/https://plainrecords.com/recall/drug/d-0502-2024/Wed, 29 May 2024 00:00:00 +0000Failed Release Testing: Out of specification for particulate matter test.https://plainrecords.com/recall/drug/d-0493-2024/https://plainrecords.com/recall/drug/d-0493-2024/Wed, 15 May 2024 00:00:00 +0000Out of specification for assayhttps://plainrecords.com/recall/drug/d-0368-2024/https://plainrecords.com/recall/drug/d-0368-2024/Wed, 20 Mar 2024 00:00:00 +0000CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.https://plainrecords.com/recall/drug/d-0350-2024/https://plainrecords.com/recall/drug/d-0350-2024/Wed, 06 Mar 2024 00:00:00 +0000Failed Dissolution Specifications: Out of specification for dissolution.https://plainrecords.com/recall/drug/d-0263-2024/https://plainrecords.com/recall/drug/d-0263-2024/Wed, 31 Jan 2024 00:00:00 +0000CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.https://plainrecords.com/recall/drug/d-0150-2024/https://plainrecords.com/recall/drug/d-0150-2024/Wed, 20 Dec 2023 00:00:00 +0000Failed Impurities/Degradation Specificationshttps://plainrecords.com/recall/drug/d-0137-2024/https://plainrecords.com/recall/drug/d-0137-2024/Wed, 13 Dec 2023 00:00:00 +0000Failed Dissolution Specificationshttps://plainrecords.com/recall/drug/d-0083-2024/https://plainrecords.com/recall/drug/d-0083-2024/Wed, 08 Nov 2023 00:00:00 +0000Failed Impurities/Degradation Specifications.https://plainrecords.com/recall/drug/d-0044-2024/https://plainrecords.com/recall/drug/d-0044-2024/Wed, 25 Oct 2023 00:00:00 +0000Failed Dissolution Specificationshttps://plainrecords.com/recall/drug/d-1172-2023/https://plainrecords.com/recall/drug/d-1172-2023/Wed, 27 Sep 2023 00:00:00 +0000Subpotent: Out of Specification result observed for low assayhttps://plainrecords.com/recall/drug/d-1082-2023/https://plainrecords.com/recall/drug/d-1082-2023/Wed, 16 Aug 2023 00:00:00 +0000Out of Specification result observed in content uniformity testinghttps://plainrecords.com/recall/drug/d-0940-2023/https://plainrecords.com/recall/drug/d-0940-2023/Wed, 02 Aug 2023 00:00:00 +0000Presence of Foreign Substance: Metal embedded in a tablet.https://plainrecords.com/recall/drug/d-0924-2023/https://plainrecords.com/recall/drug/d-0924-2023/Wed, 26 Jul 2023 00:00:00 +0000Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.https://plainrecords.com/recall/drug/d-0914-2023/https://plainrecords.com/recall/drug/d-0914-2023/Wed, 19 Jul 2023 00:00:00 +0000Failed Impurities: Out of Specification (OOS) result observed during Related Substances testinghttps://plainrecords.com/recall/drug/d-0891-2023/https://plainrecords.com/recall/drug/d-0891-2023/Wed, 05 Jul 2023 00:00:00 +0000Subpotent drughttps://plainrecords.com/recall/drug/d-0869-2023/https://plainrecords.com/recall/drug/d-0869-2023/Wed, 14 Jun 2023 00:00:00 +0000CGMP Deviationshttps://plainrecords.com/recall/drug/d-0761-2023/https://plainrecords.com/recall/drug/d-0761-2023/Wed, 31 May 2023 00:00:00 +0000Failed Dissolution Specifications; during stability testinghttps://plainrecords.com/recall/drug/d-0569-2023/https://plainrecords.com/recall/drug/d-0569-2023/Wed, 03 May 2023 00:00:00 +0000Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.https://plainrecords.com/recall/drug/d-0529-2023/https://plainrecords.com/recall/drug/d-0529-2023/Wed, 19 Apr 2023 00:00:00 +0000Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.https://plainrecords.com/recall/drug/d-0474-2023/https://plainrecords.com/recall/drug/d-0474-2023/Wed, 29 Mar 2023 00:00:00 +0000Failed Content Uniformity Specificationshttps://plainrecords.com/recall/drug/d-0262-2023/https://plainrecords.com/recall/drug/d-0262-2023/Wed, 08 Feb 2023 00:00:00 +0000Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.https://plainrecords.com/recall/drug/d-0085-2023/https://plainrecords.com/recall/drug/d-0085-2023/Wed, 28 Dec 2022 00:00:00 +0000Presence of foreign substancehttps://plainrecords.com/recall/drug/d-0068-2023/https://plainrecords.com/recall/drug/d-0068-2023/Wed, 30 Nov 2022 00:00:00 +0000Discolorationhttps://plainrecords.com/recall/drug/d-0024-2023/https://plainrecords.com/recall/drug/d-0024-2023/Wed, 09 Nov 2022 00:00:00 +0000Presence of Foreign Substancehttps://plainrecords.com/recall/drug/d-0004-2023/https://plainrecords.com/recall/drug/d-0004-2023/Wed, 05 Oct 2022 00:00:00 +0000Superpotent Drug: Out of specification for assay at the 12-month timepoint.https://plainrecords.com/recall/drug/d-1291-2022/https://plainrecords.com/recall/drug/d-1291-2022/Wed, 03 Aug 2022 00:00:00 +0000Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.https://plainrecords.com/recall/drug/d-1190-2022/https://plainrecords.com/recall/drug/d-1190-2022/Wed, 20 Jul 2022 00:00:00 +0000cGMP - Water leakagehttps://plainrecords.com/recall/drug/d-1176-2022/https://plainrecords.com/recall/drug/d-1176-2022/Wed, 13 Jul 2022 00:00:00 +0000CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.https://plainrecords.com/recall/drug/d-1155-2022/https://plainrecords.com/recall/drug/d-1155-2022/Wed, 29 Jun 2022 00:00:00 +0000Failed Tablet/Capsule Specification; oversized tablet found in a bottlehttps://plainrecords.com/recall/drug/d-1154-2022/https://plainrecords.com/recall/drug/d-1154-2022/Wed, 29 Jun 2022 00:00:00 +0000Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion