Class II · Moderate risk
Spironolactone Tablets
Presence of foreign substance: identified as aluminum.
Is Spironolactone recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Spironolactone (11 total). Check the affected lots below.
Most common reason: Unapproved drug (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Spironolactone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Spironolactone recalls on record
none so far in 2026; 11 on record, newest first
Class II · Moderate risk
Spironolactone Ophthalmic Solution 0.005 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Class I · High risk
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Class II · Moderate risk
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I · High risk
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk
All spironolactone Products
Lack of Processing Controls
Class II · Moderate risk
Spironolactone 5 mg/mL Susp
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Aldactone (spironolactone)
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class II · Moderate risk
Spironolactone tablets
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class II · Moderate risk
Spironolactone tablets
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
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