Why it was recalled
Presence of foreign substance: identified as aluminum.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # P3314, Exp 11/30/2026
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0574-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 5, 2025
- FDA report date
- Aug 13, 2025
- Quantity
- 11,328 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0574-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97391
- Address
- 2 Independence Way
- Code information
- Lot # P3314, Exp 11/30/2026
- Postal code
- 08540-6620
- Report date
- Aug 13, 2025
- Product type
- Drugs
- Recall number
- D-0574-2025
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 11,328 bottles
- Reason for recall
- Presence of foreign substance: identified as aluminum.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2025