August 2025 FDA Recall Spironolactone by Sun Pharmaceutical Industries Inc
D-0574-2025 - Presence of foreign substance
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on August 5, 2025 for the product Spironolactone. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0574-2025
Presence of foreign substance: identified as aluminum.
08-05-2025
08-13-2025
11,328 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# P3314, Exp 11/30/2026
