Pfizer Recalls Aldactone Tablets Due to Unapproved Manufacturing Site
Pfizer is recalling Aldactone (spironolactone) 100 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is related to regulatory compliance and potential efficacy issues due to an unapproved manufacturing site, rather than a direct, reported acute safety threat like contamination or injury.
Plain-English summary
Pfizer Us Pharmaceutical Group is recalling 31 bottles of Aldactone (spironolactone) tablets, USP, 100 mg. The affected product is distributed in 100-count bottles and is identified by Lot # V121573 with an expiration date of 05/17. The recall covers the United States nationwide.
The recall was initiated because changes to the dissolution profile in the distributed lots resulted from a manufacturing site change. Currently, there is no approved application supporting the alternate manufacturing site, meaning the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The product is prescription-only.
The recalled product
- Product
- ALDACTONE (SPIRONOLACTONE)
- Brand
- ALDACTONE
- Manufacturer
- Pfizer Us Pharmaceutical Group
- Category
- Drug — Prescription Medication
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: V121573
- Exp 05/17
UPCs (3)
- 0300251001314
- 0300251031311
- 0300251041310
Distribution
Distributed nationwide across the United States.
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