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

Spironolactone Tablets Recalled for Aluminum Contamination

Sun Pharmaceutical is recalling Spironolactone tablets nationwide due to the presence of aluminum, a foreign substance. Patients should consult their healthcare provider before making changes to treatment.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Aluminum contamination represents a manufacturing quality defect, but without documented harm or known high-risk pathogen profile, this meets the Moderate severity criteria.

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling Spironolactone Tablets, USP, 25 mg due to the presence of aluminum, identified as a foreign substance in the product.

The recall affects 11,328 bottles (Lot P3314, expiration date 11/30/2026) distributed nationwide. The tablets are manufactured by Frontida BioPharm, Inc. and distributed by Sun Pharmaceutical Industries, Inc.

Patients currently taking this medication should contact their healthcare provider before making any changes to their treatment. Consumers with questions may contact their healthcare provider or pharmacist.

The recalled product

Product
SPIRONOLACTONE (SPIRONOLACTONE)
Brand
SPIRONOLACTONE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug
Hazard
  • foreign-substance
  • aluminum-contamination

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.

Related recalls

Same category