Spironolactone Tablets — Class II drug recall D-0574-2025
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2025-08-13, distributed nationwide. Presence of foreign substance: identified as aluminum.
| Recall number | D-0574-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2025-08-05 |
| Classified | 2025-08-07 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 11,328 bottles |
| NDC | 53489-0143, 53489-0143-01, 53489-0143-05, 53489-0143-10, 53489-0328, 53489-0328-01, 53489-0328-02, 53489-0328-03, 53489-0328-05, 53489-0328-06, 53489-0328-07, 53489-0328-10, 53489-0329, 53489-0329-01, 53489-0329-02, 53489-0329-03, 53489-0329-05, 53489-0329-06, 53489-0329-07, 53489-0329-10 |
| Lot numbers | P3314 |
| Expiration dates | 2026-11-30 |
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
Reason for recall
Presence of foreign substance: identified as aluminum.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0574-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.