Sun Pharmaceutical Spironolactone Tablets Recall: Aluminum Foreign Substance Hazard
Sun Pharmaceutical recalls 25mg spironolactone tablets with aluminum foreign substance. This could cause harm if ingested. Contact Sun Pharmaceutical for details.
Lower-risk recall
Presence of foreign substance: identified as aluminum.
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling 25mg spironolactone tablets that contain aluminum. This foreign substance could cause harm if taken by mistake. Read more at govinfonow.com/recall/31887-sun-pharmaceutical-spironolactone-tablets-recall-aluminum-foreign-substance-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/31887-sun-pharmaceutical-spironolactone-tablets-recall-aluminum-foreign-substance-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0574-2025
Cite this page
“Sun Pharmaceutical Spironolactone Tablets Recall: Aluminum Foreign Substance Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31887-sun-pharmaceutical-spironolactone-tablets-recall-aluminum-foreign-substance-hazard. Based on FDA recall #D-0574-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0574-2025%22&limit=1).
Why it’s dangerous
The tablets contain aluminum, a foreign substance that could be harmful if ingested. This is a potential safety issue for people taking the medication.
Who’s affected
People who have the 25mg spironolactone tablets with lot number P3314. Prescriptions for this medication are at risk.
How to tell if you have this one
Check for the 25mg spironolactone tablets with lot number P3314. The product was manufactured by Frontida BioPharm, Inc. in Philadelphia, PA.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number P3314 on the packaging to confirm if your tablets are affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 8 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the affected product?
If you have the affected lot number, stop using the tablets and contact Sun Pharmaceutical for further instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0574-2025 (August 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0574-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.