FDAFDA · Food and drugs·Recall number D-0574-2025
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
Published August 13, 2025 · Recall initiated: August 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of foreign substance: identified as aluminum.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SPIRONOLACTONE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- USA Nationwide
- UPC
- 0353489143011
- Lot
- Lot # P3314, Exp 11/30/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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