DrugAug 26, 2026
Carbamazepine Tablets, USP, 200mg, 1000 count bottles recall — FDA D-0770-2026
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
Recall history in this database
Classification mix: Class II: 80, Class III: 32, Class I: 3.
DrugJul 1, 2026
Perampanel CIII Tablets, 6mg recall — FDA D-0628-2026
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugJun 17, 2026
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules recall — FDA D-0607-2026
Presence 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 solution
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugJun 17, 2026
DOXORUBICIN HYDROCHLORIDE DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL) recall — FDA D-0580-2026
Presence of Particulate matter: Particulate matter identified as glass.
Class IFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugJun 10, 2026
SUN PHARMACEUTICAL INDUSTRIES Xyvona recall — FDA D-0598-2026
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugJun 10, 2026
SUN PHARMACEUTICAL INDUSTRIES Xyvona recall — FDA D-0599-2026
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugApr 22, 2026
FLUOCINONIDE recall — FDA D-0476-2026
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugApr 22, 2026
FLUOCINONIDE recall — FDA D-0477-2026
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugApr 22, 2026
FLUOCINONIDE recall — FDA D-0475-2026
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugFeb 11, 2026
Diclofenac Sodium, Topical Gel, 3%, 100 g tube recall — FDA D-0342-2026
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugJan 21, 2026
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle recall — FDA D-0257-2026
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class IIIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugNov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle recall — FDA D-0149-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugNov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle recall — FDA D-0148-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugNov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle recall — FDA D-0150-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugNov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle recall — FDA D-0145-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugNov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle recall — FDA D-0144-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugNov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle recall — FDA D-0147-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugNov 5, 2025
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle recall — FDA D-0146-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25C, 60%RH) for Lisdexamfetamine…
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugSep 24, 2025
KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE Kit for the Preparation of Technetium recall — FDA D-0658-2025
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugJul 23, 2025
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles recall — FDA D-0516-2025
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25C, 60%RH).
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugApr 16, 2025
Gabapentin Capsules, USP 400 mg recall — FDA D-0312-2025
Cross Contamination
Class IIIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugApr 16, 2025
Gabapentin Capsules, USP 300 mg recall — FDA D-0311-2025
Cross Contamination
Class IIIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugJul 24, 2024
NITROFURANTION Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg recall — FDA D-0597-2024
Failed Dissolution Specifications
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJul 10, 2024
SUN PHARMACEUTICAL INDUSTRIES Decitabine for Injection 50mg per vial, For intravenous recall — FDA D-0582-2024
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Sun Pharmaceutical Industries, 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.