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SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC Recalls

All product recalls associated with SUN PHARMACEUTICAL INDUSTRIES INC.

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Recall Summary

Total Recalls

125

Past Year

13

Class I (Serious)

2

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 125 recalls

Febuxostat Tablets 80mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lurasidone Hydrochloride Tablets 60mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Febuxostat Tablets 40mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

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Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Lurasidone Hydrochloride Tablets 120mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Mesalamine Delayed-Release Tablets (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Zolpidem Tartrate Extended-Release Tablets 12.5mg (Sun Pharmaceutical) – Microbial Contamination ...

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Niacin Extended-Release Tablets 1000mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Niacin Extended-Release Tablets 500mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Cinacalcet Tablets 60mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Zolpidem Tartrate Extended-Release Tablets 6.25mg (Sun Pharmaceutical) – Microbial Contamination ...

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Fexofenadine Hydrochloride Tablets 180mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Liothyronine Sodium Tablets (Sun Pharma) – Impurity Concerns (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDADec 4, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

buPROPion Tablets (Sun Pharmaceutical) – Failed Dissolution (2023)

Failed Dissolution Specifications

FDANov 22, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Liothyronine Sodium Tablets (Sun Pharmaceutical) – Impurity Specs (2023)

Failed Impurities/Degradation Specifications.

Class IIModerate

FDAOct 20, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Liothyronine Sodium Tablets 5mcg (Sun) – impurity specification (2023)

Failed Impurities/Degradation Specifications.

Class IIModerate

FDAOct 20, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Bupropion Hydrochloride Tablets (Sun Pharma) – Dissolution Failure (2023)

Failed Dissolution Specifications

FDAOct 4, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Cequa Eye Solution (Sun Pharmaceutical) – Subpotent Medication (2023)

Subpotent: Out of Specification result observed for low assay

FDASep 7, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Dofetilide Capsules (Sun Pharma) – Content Uniformity Issue (2023)

Out of Specification result observed in content uniformity testing

FDAJul 18, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Methylphenidate Tablets (Sun Pharmaceutical) – foreign substance (2023)

Presence of Foreign Substance: Metal embedded in a tablet.

Class IIModerate

FDAJul 13, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Tiagabine Hydrochloride Tablets (Sun Pharma) – Impurity Failure (2023)

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

Class IIModerate

FDAJul 10, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC