The Recall Desk
HighFDA (Drugs)·D-0574-2025·Announced 2025-08-13

[pending] SPIRONOLACTONE (SPIRONOLACTONE)

Pending LLM rewrite. Source: FDA_DRUG D-0574-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Presence of foreign substance: identified as aluminum.

The recalled product

Product
SPIRONOLACTONE (SPIRONOLACTONE)
Brand
SPIRONOLACTONE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # P3314
  • Exp 11/30/2026

UPCs (2)

  • 0353489143011
  • 0353489329019

Distribution

Distributed nationwide across the United States.