CLASS II Drug recall · Reported 27 Nov 2013 · FDA Enforcement Report
Aldactone (spironolactone) tablets, USP, 100 mg recalled
Pfizer Us Pharmaceutical Group is recalling Aldactone (spironolactone) tablets, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 4 Sep 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-014-2014
- FDA event ID
- 66124
- Recalling firm
- Pfizer Us Pharmaceutical Group, New York, NY
- Brand
- Aldactone
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2013
- FDA classified
- 20 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 4 Sep 2013 | Recall initiated by company | |
| 20 Nov 2013 | Classified by FDA | +77 days |
| 27 Nov 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: V121573, Exp 05/17
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pfizer Us Pharmaceutical Group
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|---|---|---|---|---|---|
| Drug | CLASS II | Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg recalledPristiq | Pfizer Us Pharmaceutical Group | Other | Nationwide |
| Drug | CLASS I | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg recalled | Pfizer Us Pharmaceutical Group | Packaging Defects | Nationwide |
| Drug | CLASS III | Advil PM Caplets, (Ibuprofen recalled by Pfizer Us Pharmaceutical GroupAdvil Pm | Pfizer Us Pharmaceutical Group | Potency & Assay | Nationwide |
Other Spironolactone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Spironolactone Tablets, USP, 25 mg recalledSpironolactone | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS II | Spironolactone Ophthalmic Solution 0.005 mg/mL recalled | Prescription Labs | Sterility | Nationwide |
| Drug | CLASS I | Spironolactone Tablets, USP, 25 mg recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Spironolactone 5 mg/mL Susp, Health Innov Pharmacy recalled | Health Innovations Pharmacy | Sterility | NC |