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Class II · ModerateActive recall

Spironolactone

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # P3314, Exp 11/30/2026
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of foreign substance: identified as aluminum.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries, Inc.
Brand nameSPIRONOLACTONE
Generic nameSPIRONOLACTONE
Active ingredient(s)SPIRONOLACTONE
Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC53489-143-01
Show the full FDA record
Full product labelSpironolactone 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
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionUSA Nationwide
Quantity11,328 bottles
Recall initiated2025-08-05
Report date2025-08-13
Recall completed—
Recall numberD-0574-2025
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.