Recall: D-0574-2025

Class II - Potentially Harmful

Class IIClassification

2025-08-05Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

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

Reason

Presence of foreign substance: identified as aluminum.

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.