FDA Recall D-0574-2025

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 282 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot # P3314, Exp 11/30/2026

Quantity: 11,328 bottles

Reason for recall

Presence of foreign substance: identified as aluminum.

Recall record

Recall number: D-0574-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-08-05
Classified by FDA Center: 2025-08-07
FDA published: 2025-08-13
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): SPIRONOLACTONE
Generic name(s): SPIRONOLACTONE
Manufacturer(s): Sun Pharmaceutical Industries, Inc.
NDC(s): 53489-143, 53489-328, 53489-329
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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