Reported Aug 13, 2025 · Ongoing
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St,…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg
- byFrontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist
- bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
- Lot codes and dates
Lot # P3314Exp 11/30/2026
- Amount recalled
- 11,328 bottles
Where it was sold
- Nationwide
Why it was recalled
Presence of foreign substance: identified as aluminum.
This product could cause temporary or reversible health problems — stop using it.
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