Class IIReported 2025-08-13

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

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC

Reason for Recall

Presence of foreign substance: identified as aluminum.

Recall Number

D-0574-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-08-05

Reported

2025-08-13

Distribution

USA Nationwide

Code Info

Lot # P3314, Exp 11/30/2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.