Class II
Ongoing
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
This recall is currently active, issued August 13, 2025. It was issued by Sun Pharmaceutical Industries Inc.
- Recall Initiated
- August 5, 2025
- Posted
- August 13, 2025
- Recall Number
- D-0574-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,328 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of foreign substance: identified as aluminum.
Distribution
USA Nationwide
Lot / Code Info
Lot # P3314, Exp 11/30/2026
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