FDA, Sun Pharmaceuticals Issue National Recall of Spironolactone 25 mg Tablets

On August 5, 2025, the US Food and Drug Administration (FDA) announced a recall of over 11,000 100-count bottles of spironolactone 25 mg tablets due to the presence of a foreign substance later identified as aluminum.1

The recall, number D-0574-2025, includes bottles with the lot number P3314 and an expiration date of November 30, 2026. All the recalled bottles were manufactured by Frontida BioPharm, Inc., and distributed by Sun Pharmaceutical Industries, Inc. The FDA initially classified this recall as a class I, but it was elevated to class II on August 8, 2025.1

Sun Pharmaceuticals enacted the recall, putting out an alert on August 8, 2025, noting a consumer complaint reported to both companies regarding a “dark fragment” inside a spironolactone 25 mg tablet.2

The American College of Cardiology (ACC) and American Heart Association (AHA) suggest spironolactone for use in patients with heart failure with mid-range ejection fraction (HFmrEF) with poorly controlled hypertension, as it substantially reduces the risk of the primary composite outcome of cardiovascular death. The standard starting dose is set at 25 mg orally daily, potentially increasing to 50 mg daily after a month.3

Spironolactone is a mineralocorticoid receptor antagonist, antagonizing the effect of aldosterone and eventually leading to a reduction in fibrosis and an improvement in left ventricular function. It can also decrease extracellular matrix turnover and myocardial collagen content, thereby improving endothelial vasomotor dysfunction.4

The medication was initially approved for the treatment of hypertension in 1960. In 2023, spironolactone was the 52nd most prescribed drug in the US, with roughly 12,777,045 prescriptions assigned to roughly 3,515,708 patients. Additionally, 67.6% of all dispensed forms of spironolactone were in 25 mg capsules or tablets. However, despite a steady increase in prescription rank year to year since 2014, this number is still subpar based on the broad nature of the medication’s labeling.5

The 2020 Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial reinforced the effectiveness of spironolactone as an add-on medication for patients with HFpEF with resistant hypertension. Notably, the results specified spironolactone’s efficacy when taken in tandem with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, calcium-channel blockers, and diuretics.6

The 11,328 bottles which have been recalled were distributed nationwide. The FDA has not issued a press release for the recall.1

References

1. US Food and Drug Administration. Recall Number D-0574-2025. August 5, 2025. Accessed August 12, 2025. https://www.accessdata.fda.gov/scripts/ires/?Product=215486

2. Sun Pharmaceutical Industries Ltd. Recall Alert: Sprionolactone Tablets, USP, 25 mg. August 8, 2025. Accessed August 12, 2025. https://www.pharmacy.ca.gov/about/recall_alerts/080825_sun.pdf

3. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18). doi:10.1161/cir.0000000000001063

4. Kosmas CE, Silverio D, Sourlas A, Montan PD, Guzman E. Role of spironolactone in the treatment of heart failure with preserved ejection fraction. Ann Transl Med. 2018;6(23):461. doi:10.21037/atm.2018.11.16

5. Kane SP. Spironolactone, ClinCalc DrugStats Database, Version 2025.08. ClinCalc: https://clincalc.com/DrugStats/Drugs/Spironolactone. Updated August 10, 2025. Accessed August 12, 2025.

6. Tsujimoto T, Kajio H. Spironolactone use and improved outcomes in patients with heart failure with preserved ejection fraction with resistant hypertension. Journal of the American Heart Association. 2020;9(23). doi:10.1161/jaha.120.018827