Spironolactone 25 mg tablets recalled after aluminum was found in product
Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a metal foreign substance identified in an oral tablet, with no injury reported in the source.
Plain-English summary
Spironolactone Tablets, USP, 25 mg, 100-count bottles, prescription only, manufactured by Frontida BioPharm, Inc. of Philadelphia, Pennsylvania and distributed by Sun Pharmaceutical Industries, Inc. of Cranbury, New Jersey, NDC 53489-143-01, are being recalled. The action covers 11,328 bottles.
The stated reason is the presence of a foreign substance identified as aluminum. The FDA classified the action as Class II. The source does not report any injury having occurred.
The affected lot is P3314, expiring 11/30/2026. Distribution was nationwide in the USA.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.
The recalled product
- Product
- SPIRONOLACTONE (SPIRONOLACTONE)
- Brand
- SPIRONOLACTONE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Oral tablet
- Affected units
- 11,328
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 # P3314
- Exp 11/30/2026
UPCs (2)
- 0353489143011
- 0353489329019
Distribution
Distributed nationwide across the United States.
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