FDA recall D-0574-2025

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 for recall

Presence of foreign substance: identified as aluminum.

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2025-08-05

Report date

2025-08-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2025