Spironolactone recalls

The FDA has published 8 recalls involving Spironolactone since 2013. The latest was reported on 13 Aug 2025. Most were for potency & assay. Greenstone has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2013

Last 12 months0reported

Class I113% of total

Ongoing3latest 13 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 1Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 13%Class II 7 88%Class III 0 0%

Why spironolactone is recalled

Companies

Brands

Spironolactone113%
Aldactone113%

By year

2025113%
2021338%
2015113%
2013338%

Ongoing spironolactone recalls

3 active

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Drug	CLASS II	Spironolactone Tablets, USP, 25 mg recalledSpironolactone	SUN Pharmaceutical Industries	Other	Nationwide
24 Mar 2021Drug	CLASS I	Spironolactone Tablets, USP, 25 mg recalled by Bryant Ranch Prepack	Bryant Ranch Prepack	Packaging Defects	Nationwide
24 Mar 2021Drug	CLASS II	Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack	Bryant Ranch Prepack	Packaging Defects	Nationwide

All spironolactone recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Drug	CLASS II	Spironolactone Tablets, USP, 25 mg recalledSpironolactone	SUN Pharmaceutical Industries	Other	Nationwide
22 Sep 2021Drug	CLASS II	Spironolactone Ophthalmic Solution 0.005 mg/mL recalled	Prescription Labs	Sterility	Nationwide
24 Mar 2021Drug	CLASS I	Spironolactone Tablets, USP, 25 mg recalled by Bryant Ranch Prepack	Bryant Ranch Prepack	Packaging Defects	Nationwide
24 Mar 2021Drug	CLASS II	Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack	Bryant Ranch Prepack	Packaging Defects	Nationwide
20 May 2015Drug	CLASS II	Spironolactone 5 mg/mL Susp, Health Innov Pharmacy recalled	Health Innovations Pharmacy	Sterility	NC
27 Nov 2013Drug	CLASS II	Spironolactone tablets, USP 50 mg recalled by Greenstone	Greenstone	Potency & Assay	Nationwide
27 Nov 2013Drug	CLASS II	Aldactone (spironolactone) tablets, USP, 100 mg recalledAldactone	Pfizer Us Pharmaceutical Group	Potency & Assay	Nationwide
27 Nov 2013Drug	CLASS II	Spironolactone tablets, USP 25 mg recalled by Greenstone	Greenstone	Potency & Assay	Nationwide

Should you stop taking Spironolactone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.