Spironolactone Tablet, Film Coated
FDA Recall NDC 53489-328
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Spironolactone (NDC 53489-328). A significant event, classified as Class II, was initiated on Aug 05, 2025 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Presence of foreign substance: identified as aluminum."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of foreign substance: identified as aluminum.
Aug 05, 2025
Aug 13, 2025
11,328 bottles
Recall Profile & Regulatory Data
Event ID
97391
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# P3314, Exp 11/30/2026
Affected Packages Involved in this Recall
53489-143-01Product
53489-143-05Product
53489-143-10Product
53489-328-07Product
53489-328-02Product
53489-328-06Product
53489-328-01Product
53489-328-03Product
53489-328-05Product
53489-328-10Product
53489-329-07Product
53489-329-02Product
53489-329-06Product
53489-329-01Product
53489-329-03Product
53489-329-05Product
53489-329-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
