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 # P3314
    • Exp 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:23 PM UTC

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