FDA Drug recall D-0574-2025
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124,…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124,… by Sun Pharmaceutical Industries, citing presence of foreign substance: identified as aluminum.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0574-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-05 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Presence of foreign substance: identified as aluminum.
Identifiers
| ndc | 53489-143-01 |
|---|---|
| ndc | 53489-143-05 |
| ndc | 53489-143-10 |
| ndc | 53489-328-07 |
| ndc | 53489-328-02 |
| ndc | 53489-328-06 |
| ndc | 53489-328-01 |
| ndc | 53489-328-03 |
| ndc | 53489-328-05 |
| ndc | 53489-328-10 |
| ndc | 53489-329-07 |
| ndc | 53489-329-02 |
| ndc | 53489-329-06 |
| ndc | 53489-329-01 |
| ndc | 53489-329-03 |
| ndc | 53489-329-05 |
| ndc | 53489-329-10 |
| code_info | Lot # P3314, Exp 11/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0574-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.