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Drug FDA Class II Ongoing Foreign material

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

SUN PHARMACEUTICAL INDUSTRIES INC Published Aug 13, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of foreign substance: identified as aluminum.

Hazards

Aluminum · primary

Affected products (1)

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

SPIRONOLACTONE · 11,328 bottles

NDC: 53489-143, 53489-328, 53489-329, 53489-143-01, 53489-143-05, 53489-143-10, 53489-328-07, 53489-328-02, 53489-328-06, 53489-328-01, 53489-328-03, 53489-328-05, 53489-328-10, 53489-329-07, 53489-329-02, 53489-329-06, 53489-329-01, 53489-329-03, 53489-329-05, 53489-329-10
Lot codes: P3314
Code info: Lot # P3314, Exp 11/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 5, 2025
  2. Published
    Aug 13, 2025
Recall number
D-0574-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.