CLASS II ONGOING Drug recall · Reported 13 Aug 2025 · FDA Enforcement Report
Spironolactone Tablets, USP, 25 mg recalled
SUN Pharmaceutical Industries is recalling Spironolactone Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 5 Aug 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0574-2025
- FDA event ID
- 97391
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Spironolactone
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Aug 2025
- FDA classified
- 7 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 5 Aug 2025 | Recall initiated by company | |
| 7 Aug 2025 | Classified by FDA | +2 days |
| 13 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance: identified as aluminum.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign substance: identified as aluminum.
Which lots are affected?
Lot # P3314, Exp 11/30/2026
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
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Other Spironolactone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Spironolactone Ophthalmic Solution 0.005 mg/mL recalled | Prescription Labs | Sterility | Nationwide |
| Drug | CLASS I | Spironolactone Tablets, USP, 25 mg recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Spironolactone 5 mg/mL Susp, Health Innov Pharmacy recalled | Health Innovations Pharmacy | Sterility | NC |
| Drug | CLASS II | Spironolactone tablets, USP 50 mg recalled by Greenstone | Greenstone | Potency & Assay | Nationwide |