Sun Pharmaceutical Industries Inc recalls

95 recalls in our records from 2013 to 2026: 95 FDA drugs.

Recalls with full detail pages

• FDA · DrugsClass IJun 17, 2026

  Sun Pharmaceutical Industries Inc drug recall: DOXOrubin Hydrochloride Liposome injection

  Presence of Particulate matter: Particulate matter identified as glass.

Earlier and other recalls

These link to the official agency notice.

• FDA · DrugsClass IIIOct 14, 2026

  Sun Pharmaceutical Industries Inc drug recall: Tretinoin Cream USP Official notice ↗

  Failed Impurities/Degradation Specifications

• FDA · DrugsClass IIAug 26, 2026

  Sun Pharmaceutical Industries Inc drug recall: Carbamazepine Tablets Official notice ↗

  CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

• FDA · DrugsClass IIIJul 8, 2026

  Sun Pharmaceutical Industries Inc drug recall: Fexofenadine Hydrochloride Tablets Official notice ↗

  Failed Impurities/Degradation Specifications

• FDA · DrugsClass IIJul 1, 2026

  Sun Pharmaceutical Industries Inc drug recall: Perampanel CIII Tablets Official notice ↗

  Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

• FDA · DrugsClass IIJun 17, 2026

  Sun Pharmaceutical Industries Inc drug recall: Budesonide Inhalation Suspension Official notice ↗

  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…

• FDA · DrugsClass IIJun 10, 2026

  Sun Pharmaceutical Industries Inc drug recall: Xyvona Official notice ↗

  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

• FDA · DrugsClass IIApr 22, 2026

  Sun Pharmaceutical Industries Inc drug recall: Fluocinonide Official notice ↗

  Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

• FDA · DrugsClass IIFeb 11, 2026

  Sun Pharmaceutical Industries Inc drug recall: Diclofenac Sodium Official notice ↗

  Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

• FDA · DrugsClass IIIJan 21, 2026

  Sun Pharmaceutical Industries Inc drug recall: Fluocinolone Acetonide Solution Topical Solution USP Official notice ↗

  Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

• FDA · DrugsClass IIIJan 21, 2026

  Sun Pharmaceutical Industries Inc drug recall: Clindamycin Phosphate USP Official notice ↗

  Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

• FDA · DrugsClass IINov 5, 2025

  Sun Pharmaceutical Industries Inc drug recall: Lisdexamfetamine Dimesylate Capsules Official notice ↗

  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…

• FDA · DrugsClass IISep 24, 2025

  Sun Pharmaceutical Industries Inc drug recall: Kit for the Preparation of Technetium Tc 99m Mertiatide Official notice ↗

  Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

• FDA · DrugsClass IIAug 13, 2025

  Sun Pharmaceutical Industries Inc drug recall: Spironolactone Tablets Official notice ↗

  Presence of foreign substance: identified as aluminum.

• FDA · DrugsClass IIJul 23, 2025

  Sun Pharmaceutical Industries Inc drug recall: Lisdexamfetamine Dimesylate Capsules Official notice ↗

  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).

• FDA · DrugsClass IIIApr 16, 2025

  Sun Pharmaceutical Industries Inc drug recall: Gabapentin Capsules Official notice ↗

  Cross Contamination

• FDA · DrugsClass IIMar 12, 2025

  Sun Pharmaceutical Industries Inc drug recall: Morphine Sulfate Extended-Release Tablets Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IIJul 24, 2024

  Sun Pharmaceutical Industries Inc drug recall: Nitrofurantoin Capsules Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IIJul 10, 2024

  Sun Pharmaceutical Industries Inc drug recall: Decitabine for Injection 50mg per vial Official notice ↗

  CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

• FDA · DrugsClass IIIMay 29, 2024

  Sun Pharmaceutical Industries Inc drug recall: Xelpros Official notice ↗

  Failed Release Testing: Out of specification for particulate matter test.

• FDA · DrugsClass IIMay 15, 2024

  Sun Pharmaceutical Industries Inc drug recall: Amphotericin B Liposome for Injection Official notice ↗

  Out of specification for assay

• FDA · DrugsClass IIMar 20, 2024

  Sun Pharmaceutical Industries Inc drug recall: Febuxostat Tablets 40mg Official notice ↗

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

• FDA · DrugsClass IIMar 6, 2024

  Sun Pharmaceutical Industries Inc drug recall: Mesalamine Extended-Release Capsules Official notice ↗

  Failed Dissolution Specifications: Out of specification for dissolution.

• FDA · DrugsClass IIJan 31, 2024

  Sun Pharmaceutical Industries Inc drug recall: Cinacalcet Tablets 60mg Official notice ↗

  CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

• FDA · DrugsClass IIDec 20, 2023

  Sun Pharmaceutical Industries Inc drug recall: Liothyronine Sodium Tablets Official notice ↗

  Failed Impurities/Degradation Specifications

• FDA · DrugsClass IIIDec 13, 2023

  Sun Pharmaceutical Industries Inc drug recall: buPROPion Hydrochloride Extended-Release Tablets Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IINov 8, 2023

  Sun Pharmaceutical Industries Inc drug recall: Liothyronine Sodium Tablets Official notice ↗

  Failed Impurities/Degradation Specifications.

• FDA · DrugsClass IIIOct 25, 2023

  Sun Pharmaceutical Industries Inc drug recall: Bupropion Hydrochloride Extended-Release Tablets USP Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IIISep 27, 2023

  Sun Pharmaceutical Industries Inc drug recall: Cequa Official notice ↗

  Subpotent: Out of Specification result observed for low assay

• FDA · DrugsClass IIIAug 16, 2023

  Sun Pharmaceutical Industries Inc drug recall: Dofetilide Capsules 500 mcg Official notice ↗

  Out of Specification result observed in content uniformity testing

• FDA · DrugsClass IIAug 2, 2023

  Sun Pharmaceutical Industries Inc drug recall: Methylphenidate Hydrochloride Tablets Official notice ↗

  Presence of Foreign Substance: Metal embedded in a tablet.

• FDA · DrugsClass IIIJul 26, 2023

  Sun Pharmaceutical Industries Inc drug recall: Loteprednol Etabonate Ophthalmic Suspension Official notice ↗

  Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

• FDA · DrugsClass IIJul 19, 2023

  Sun Pharmaceutical Industries Inc drug recall: Tiagabine Hydrochloride Tablets Official notice ↗

  Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

• FDA · DrugsClass IIJul 5, 2023

  Sun Pharmaceutical Industries Inc drug recall: Amphotericin B Liposome for Injection Official notice ↗

  Subpotent drug

• FDA · DrugsClass IIJun 14, 2023

  Sun Pharmaceutical Industries Inc drug recall: Buprenorphine Sublingual Tablets Official notice ↗

  CGMP Deviations

• FDA · DrugsClass IIMay 31, 2023

  Sun Pharmaceutical Industries Inc drug recall: buPROPrion Hydrochloride Extended-Release Tablets Official notice ↗

  Failed Dissolution Specifications; during stability testing

• FDA · DrugsClass IIMay 3, 2023

  Sun Pharmaceutical Industries Ltd. drug recall: Fyremadel Official notice ↗

  Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.

• FDA · DrugsClass IIIApr 19, 2023

  Sun Pharmaceutical Industries Inc drug recall: Norepinephrine Bitartrate Injection Official notice ↗

  Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product…

• FDA · DrugsClass IIIMar 29, 2023

  Sun Pharmaceutical Industries Inc drug recall: Dofetilide Capsules Official notice ↗

  Failed Content Uniformity Specifications

• FDA · DrugsClass IIFeb 8, 2023

  Sun Pharmaceutical Industries Inc drug recall: Diltiazem Hydrochloride Extended-Release Capsules Official notice ↗

  Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

• FDA · DrugsClass IIDec 28, 2022

  Sun Pharmaceutical Industries Inc drug recall: Oxcarbazepine Tablets 600mg Official notice ↗

  Presence of foreign substance

• FDA · DrugsClass IINov 30, 2022

  Sun Pharmaceutical Industries Inc drug recall: Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg*… Official notice ↗

  Discoloration

• FDA · DrugsClass IINov 9, 2022

  Sun Pharmaceutical Industries Inc drug recall: Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg Official notice ↗

  Presence of Foreign Substance

• FDA · DrugsClass IIIOct 5, 2022

  Sun Pharmaceutical Industries Inc drug recall: Esomeprazole Magnesium Delayed-Release Capsules Official notice ↗

  Superpotent Drug: Out of specification for assay at the 12-month timepoint.

• FDA · DrugsClass IIAug 3, 2022

  Sun Pharmaceutical Industries Inc drug recall: Divalproex Sodium Delayed-Release Tablets Official notice ↗

  Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

• FDA · DrugsClass IIJul 20, 2022

  Sun Pharmaceutical Industries Inc drug recall: Testosterone Cypionate Injection Official notice ↗

  cGMP - Water leakage

• FDA · DrugsClass IIJul 13, 2022

  Sun Pharmaceutical Industries Inc drug recall: Testosterone Cypionate Injection Official notice ↗

  CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

• FDA · DrugsClass IIJun 29, 2022

  Sun Pharmaceutical Industries Inc drug recall: Testosterone Cypionate Injection Official notice ↗

  Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion

• FDA · DrugsClass IIJun 29, 2022

  Sun Pharmaceutical Industries Inc drug recall: Testosterone Cypionate Injection Official notice ↗

  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…

• FDA · DrugsClass IIJun 29, 2022

  Sun Pharmaceutical Industries Inc drug recall: Clonazepam Orally Disintegrating Tablets Official notice ↗

  Failed Tablet/Capsule Specification; oversized tablet found in a bottle

• FDA · DrugsClass IIJun 22, 2022

  Sun Pharmaceutical Industries Inc drug recall: medroxyPROGESTERone Acetate Injectable Suspension Official notice ↗

  Lack of assurance of sterility

• FDA · DrugsClass IIIMay 18, 2022

  Sun Pharmaceutical Industries Inc drug recall: buPROPion Hydrochloride Extended-Release Tablet Official notice ↗

  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…

• FDA · DrugsClass IIIApr 13, 2022

  Sun Pharmaceutical Industries Inc drug recall: Cequa Official notice ↗

  Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.

• FDA · DrugsClass IIFeb 23, 2022

  Sun Pharmaceutical Industries Inc drug recall: Chlorthalidone Tablets USP 25 mg Official notice ↗

  Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

• FDA · DrugsClass IIJan 12, 2022

  Sun Pharmaceutical Industries Inc drug recall: Pregabalin Capsules Official notice ↗

  Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.

• FDA · DrugsClass IINov 17, 2021

  Sun Pharmaceutical Industries Inc drug recall: Tadalafil Tablets Official notice ↗

  Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

• FDA · DrugsClass IIINov 3, 2021

  Sun Pharmaceutical Industries Inc drug recall: Loratadine-D Extended-Release Tablets Official notice ↗

  Failed Moisture Limits

• FDA · DrugsClass IIAug 18, 2021

  Sun Pharmaceutical Industries Inc drug recall: Venlafaxine Tablets Official notice ↗

  Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg

• FDA · DrugsClass IIIMay 26, 2021

  Sun Pharmaceutical Industries Inc drug recall: Cequa Official notice ↗

  Subpotent and Presence of Particulates .

• FDA · DrugsClass IIMay 19, 2021

  Sun Pharmaceutical Industries Inc drug recall: Metformin HCl Extended-Release Tablets Official notice ↗

  Presence of foreign substance: identified as activated carbon.

• FDA · DrugsClass IIApr 21, 2021

  Sun Pharmaceutical Industries Inc drug recall: Riomet Official notice ↗

  Microbial Contamination of Non-Sterile Product

• FDA · DrugsClass IIIApr 14, 2021

  Sun Pharmaceutical Industries Inc drug recall: Metformin HCl Extended-Release Tablets Official notice ↗

  Failed Moisture Limits: Out of specification for water content

• FDA · DrugsClass IIApr 14, 2021

  Sun Pharmaceutical Industries Inc drug recall: Ganirelix Acetate Injection Official notice ↗

  Failed Impurities/Degradation Specifications

• FDA · DrugsClass IIIMar 10, 2021

  Sun Pharmaceutical Industries Inc drug recall: Cequa Official notice ↗

  Subpotent

• FDA · DrugsClass IIIFeb 17, 2021

  Sun Pharmaceutical Industries Inc drug recall: Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only… Official notice ↗

  Failed Impurity/Degradation Specifications

• FDA · DrugsClass IIIFeb 3, 2021

  Sun Pharmaceutical Industries Inc drug recall: Testosterone Cypionate Injection Official notice ↗

  Incorrect Labeling: Incorrect lot number on secondary packaging

• FDA · DrugsClass IIOct 7, 2020

  Sun Pharmaceutical Industries Inc drug recall: Riomet Er Official notice ↗

  CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.

• FDA · DrugsClass IIIAug 5, 2020

  Sun Pharmaceutical Industries Inc drug recall: Clonazepam Orally Disintegrating Tablets Official notice ↗

  Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

• FDA · DrugsClass IIMar 25, 2020

  Sun Pharmaceutical Industries, Inc. drug recall: Doxycycline Capsules Official notice ↗

  CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.

• FDA · DrugsClass IIMar 25, 2020

  Sun Pharmaceutical Industries, Inc. drug recall: Atorvastatin Calcium Tablets Official notice ↗

  Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.

• FDA · DrugsClass IIJan 22, 2020

  Sun Pharmaceutical Industries, Inc. drug recall: Testosterone Cypionate for Injection Official notice ↗

  cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

• FDA · DrugsClass IIJan 22, 2020

  Sun Pharmaceutical Industries, Inc. drug recall: Sumatriptan Succinate Tablets Official notice ↗

  Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.

• FDA · DrugsClass IIJun 26, 2019

  Sun Pharmaceutical Industries, Inc. drug recall: Allergy Relief D Official notice ↗

  Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the…

• FDA · DrugsClass IIFeb 6, 2019

  Sun Pharmaceutical Industries, Inc. drug recall: BromSite Official notice ↗

  Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.

• FDA · DrugsClass IIIJan 30, 2019

  Sun Pharmaceutical Industries, Inc. drug recall: Loperamide Hcl Tablets Usp Official notice ↗

  Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

• FDA · DrugsClass IJan 16, 2019

  Sun Pharmaceutical Industries, Inc. drug recall: Vecuronium Bromide for Injection 10 mg* Official notice ↗

  Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

• FDA · DrugsClass IIIDec 26, 2018

  Sun Pharmaceutical Industries, Inc. drug recall: Absorica Official notice ↗

  Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

• FDA · DrugsClass IIAug 1, 2018

  Sun Pharmaceutical Industries, Inc. drug recall: Testosterone Cypionate Injection Official notice ↗

  Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.

• FDA · DrugsClass IIJul 25, 2018

  Sun Pharmaceutical Industries, Inc. drug recall: Metformin Hydrochloride Extended Release Tablets Official notice ↗

  Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of…

• FDA · DrugsClass IIIMay 23, 2018

  Sun Pharmaceutical Industries, Inc. drug recall: Riomet Official notice ↗

  Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

• FDA · DrugsClass IIMay 23, 2018

  Sun Pharmaceutical Industries, Inc. drug recall: Sulfamethoxazole and Trimethoprim Tablets USP Official notice ↗

  Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter…

• FDA · DrugsClass IIIFeb 21, 2018

  Sun Pharmaceutical Industries, Inc. drug recall: Azelastine HCl Nasal Solution Official notice ↗

  Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during…

• FDA · DrugsClass IIJan 31, 2018

  Sun Pharmaceutical Industries, Inc. drug recall: DOXOrubicin Hydrochloride Liposome Injection Official notice ↗

  Lack Of Assurance Of Sterility

• FDA · DrugsClass IIDec 20, 2017

  Sun Pharmaceutical Industries, Inc. drug recall: Riomet Official notice ↗

  Microbial Contamination of Non-Sterile Products

• FDA · DrugsClass IIIMay 31, 2017

  Sun Pharmaceutical Industries, Inc. drug recall: Children's Cetirizine Hydrochloride Chewable Tablets Official notice ↗

  Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.

• FDA · DrugsClass IIIMay 17, 2017

  Sun Pharmaceutical Industries, Inc. drug recall: Olanzapine Tablets Official notice ↗

  Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

• FDA · DrugsClass IIMar 29, 2017

  Sun Pharmaceutical Industries, Inc. drug recall: Testosterone Cypionate Injection Official notice ↗

  Presence of Particulate Matter

• FDA · DrugsClass IIMar 8, 2017

  Sun Pharmaceutical Industries, Inc. drug recall: Alfuzosin Hydrochloride Extended-release Tablets Official notice ↗

  Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.

• FDA · DrugsClass IIFeb 8, 2017

  Sun Pharmaceutical Industries, Inc. drug recall: Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a)… Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IIIFeb 1, 2017

  Sun Pharmaceutical Industries, Inc. drug recall: buPROPion Hydrochloride Extended-release Tablets Official notice ↗

  Failed Dissolution Specifications; 18 month stability time point

• FDA · DrugsClass IIINov 30, 2016

  Sun Pharmaceutical Industries, Inc. drug recall: Kenalog Official notice ↗

  Failed Stability Specifications: Low Out of Specification results for alcohol content.

• FDA · DrugsClass IIIOct 12, 2016

  Sun Pharmaceutical Industries, Inc. drug recall: buPROPion Hydrochloride Extended-release Tablets Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IIISep 28, 2016

  Sun Pharmaceutical Industries, Inc. drug recall: Carvediol Tablets Official notice ↗

  Failed Impurities/Degradation Specifications

• FDA · DrugsClass IIIJul 27, 2016

  Sun Pharmaceutical Industries, Inc. drug recall: buPROPion Hydrochloride Extended Release Tablets USP Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IIJul 17, 2013

  Sun Pharmaceutical Industries Inc. drug recall: Nimodipine Capsules 30 mg Official notice ↗

  Crystallization; crystallized nimodipine

Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.