DrugMay 15, 2024
Amphotericin B Liposome for Injection, 50mg vials recall — FDA D-0493-2024
Out of specification for assay
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
Recall history in this database
Classification mix: Class II: 80, Class III: 32, Class I: 3.
DrugMar 20, 2024
Febuxostat Tablets 80mg recall — FDA D-0369-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugMar 20, 2024
Febuxostat Tablets 40mg recall — FDA D-0368-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugMar 6, 2024
Mesalamine Extended-Release Capsules, USP 500mg recall — FDA D-0350-2024
Failed Dissolution Specifications: Out of specification for dissolution.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Lurasidone Hydrochloride Tablets 60mg recall — FDA D-0266-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg recall — FDA D-0272-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet recall — FDA D-0268-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Cinacalcet Tablets 60mg recall — FDA D-0263-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Lurasidone Hydrochloride Tablets 120mg recall — FDA D-0267-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Niacin Extended-Release Tablets, USP 500mg recall — FDA D-0270-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Niacin Extended-Release Tablets, USP 1000mg recall — FDA D-0269-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Febuxostat Tablets 80 mg recall — FDA D-0265-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Febuxostat Tablets 40mg recall — FDA D-0264-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg recall — FDA D-0271-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 recall — FDA D-0273-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugDec 20, 2023
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle recall — FDA D-0150-2024
Failed Impurities/Degradation Specifications
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugNov 8, 2023
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles recall — FDA D-0083-2024
Failed Impurities/Degradation Specifications.
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugNov 8, 2023
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles recall — FDA D-0084-2024
Failed Impurities/Degradation Specifications.
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugOct 25, 2023
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle recall — FDA D-0044-2024
Failed Dissolution Specifications
Class IIIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugSep 27, 2023
Cequa recall — FDA D-1172-2023
Subpotent: Out of Specification result observed for low assay
Class IIIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugAug 16, 2023
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle recall — FDA D-1082-2023
Out of Specification result observed in content uniformity testing
Class IIIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJul 26, 2023
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a recall — FDA D-0924-2023
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Class IIIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJul 19, 2023
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle recall — FDA D-0914-2023
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugApr 19, 2023
Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop recall — FDA D-0529-2023
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class IIIFDA: TerminatedSUN 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.