Home / Brands / SUN PHARMACEUTICAL INDUSTRIES
SUN PHARMACEUTICAL INDUSTRIES Recalls
137 recalls on record · July 17, 2013 to July 8, 2026 · Drugs
Recalls by year
13
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories,
Hazard: Failed Impurities/Degradation Specifications
July 1, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262476
Hazard: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
June 17, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pou
Hazard: 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
June 17, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufacture
Hazard: Presence of Particulate matter: Particulate matter identified as glass.
June 10, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc
Hazard: 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
June 10, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc
Hazard: 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
April 22, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,
Hazard: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
April 22, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,
Hazard: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
April 22, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1,
Hazard: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
February 11, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L
Hazard: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
January 21, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmace
Hazard: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
January 21, 2026DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.
Hazard: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
November 5, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun
Hazard: 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.
September 24, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. B
Hazard: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
August 13, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Phila
Hazard: Presence of foreign substance: identified as aluminum.
July 23, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Bru
Hazard: 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).
April 16, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC
Hazard: Cross Contamination
April 16, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, ND
Hazard: Cross Contamination
March 12, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., N
Hazard: Failed Dissolution Specifications
July 24, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laborato
Hazard: Failed Dissolution Specifications
July 10, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Via
Hazard: CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
May 29, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceuti
Hazard: Failed Release Testing: Out of specification for particulate matter test.
May 15, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury
Hazard: Out of specification for assay
March 20, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.