FDAHealthAugust 5, 2025
SUN PHARMACEUTICAL INDUSTRIES INC — Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceuti
⚠️ Presence of foreign substance: identified as aluminum.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 5, 2025
USA Nationwide
What's affected?
- 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
- SPIRONOLACTONE
- UPC
- 0353489143011
- Lot code
- P3314
Additional details
Lot # P3314, Exp 11/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,328 bottles.
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