SUN PHARMACEUTICAL INDUSTRIES INC recalls Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Phil…

Recall date

August 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0574-2025

FDA classification

Class II

Brand / firm

SUN PHARMACEUTICAL INDUSTRIES INC

Sold / distributed

USA Nationwide

Why it was recalled

Presence of foreign substance: identified as aluminum.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01