Drug Enforcement D-0574-2025

Presence of foreign substance: identified as aluminum.

Status

Ongoing

Classification

Class II

Report Date

August 13, 2025

Termination Date

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Product Information

Product description
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
Product quantity
11,328 bottles
Reason for recall
Presence of foreign substance: identified as aluminum.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0574-2025
Event ID
97391
Recall initiation date
August 5, 2025
Center classification date
August 7, 2025
Code info
Lot # P3314, Exp 11/30/2026
More code info
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