FDA Drugs recall ·
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg recall
- Recall number
- D-0574-2025
- Date
- (initiated August 5, 2025)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,328 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Presence of foreign substance: identified as aluminum.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # P3314, Exp 11/30/2026
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0574-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.