Sun Pharmaceutical Industries recalls
57 official recalls and safety alerts involving Sun Pharmaceutical Industries since 2021-11, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Sun Pharmaceutical Industries or the relevant agency.
- 2026-10-14
USSUN PHARMACEUTICAL INDUSTRIES INC recalls Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro…
Failed Impurities/Degradation Specifications
- 2026-08-26
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa…
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
- 2026-07-08
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc.,…
Failed Impurities/Degradation Specifications
- 2026-07-01
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761,…
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
- 2026-06-17
- US
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 pouches…
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
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for:…
Presence of Particulate matter: Particulate matter identified as glass.
- 2026-06-10
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New…
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
- 2026-04-22
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist.…
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- 2026-02-11
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T…
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- 2026-01-21
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical…
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc.,…
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- 2025-11-05
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick,…
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.
- 2025-09-24
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc.…
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
- 2025-08-13
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St,…
Presence of foreign substance: identified as aluminum.
- 2025-07-23
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New…
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 · DrugSUN PHARMACEUTICAL INDUSTRIES INCRecalled units were distributed to 17 distributors who may have further…Official notice → - 2025-04-16
- US
- 2025-03-12
- US
- 2024-07-24
- US
- 2024-07-10
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial,…
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
- 2024-05-29
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical…
Failed Release Testing: Out of specification for particulate matter test.
- 2024-05-15
- US
- 2024-03-20
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,…
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-03-06
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical…
Failed Dissolution Specifications: Out of specification for dissolution.
- 2024-01-31
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc.,…
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2023-12-20
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc.…
Failed Impurities/Degradation Specifications
- 2023-12-13
- US
- 2023-11-08
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries,…
Failed Impurities/Degradation Specifications.
- 2023-10-25
- US
- 2023-09-27
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only,…
Subpotent: Out of Specification result observed for low assay
- 2023-08-16
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey…
Out of Specification result observed in content uniformity testing
- 2023-08-02
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New…
Presence of Foreign Substance: Metal embedded in a tablet.
- 2023-07-26
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#…
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
- 2023-07-19
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512,…
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
- 2023-07-05
- US
- 2023-06-14
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
CGMP Deviations
FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCProduct was distributed to 19 distributors nationwide.Official notice → - 2023-05-31
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical…
Failed Dissolution Specifications; during stability testing
- 2023-05-03
- US
Sun Pharmaceutical Industries Ltd. recalls Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous…
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
- 2023-04-19
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in…
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
- 2023-03-29
- US
- 2023-02-08
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical…
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
- 2022-12-28
- US
- 2022-11-30
- US
- 2022-11-09
- US
- 2022-10-05
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories…
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- 2022-08-03
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries,…
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
- 2022-07-20
- US
- 2022-07-13
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries…
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
- 2022-06-29
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd.…
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical…
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical…
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.
- 2022-06-22
- US
- 2022-05-18
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical…
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.
- 2022-04-13
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box,…
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
- 2022-02-23
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St.…
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
- 2022-01-12
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512,…
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
- 2021-11-17
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by:…
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCDistributed to one distributor who may have further distribute the product…Official notice → - 2021-11-03
- US