Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0025-1031-31 recalled?

Aldactone · 100 TABLET, FILM COATED in 1 BOTTLE (0025-1031-31)

Yes — this exact package was recalled

1 FDA recall names the code 0025-1031-31 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
spironolactone
Strength
SPIRONOLACTONE 100 mg/1
Form
Tablet, Film Coated · Oral
Labeler
Pfizer Laboratories Div Pfizer Inc
Type
Human Prescription Drug
Product code
0025-1031

Recalls naming this package

Class II ยท 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.

Terminated Unapproved drug Pfizer Us Pharmaceutical Group NDC 0025-1031-31 D-014-2014

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler