Recalls / Class II
Class IID-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
- Brand name
- Spironolactone
- Generic name
- Spironolactone
- Active ingredient
- Spironolactone
- Route
- Oral
- NDCs
- 53489-143, 53489-328, 53489-329
- FDA application
- ANDA089424
- Affected lot / code info
- Lot # P3314, Exp 11/30/2026
Why it was recalled
Presence of foreign substance: identified as aluminum.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 11,328 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-08-05
- FDA classified
- 2025-08-07
- Posted by FDA
- 2025-08-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0574-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.