FDA-Drug2025-08-13Class II
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
Hazard
Presence of foreign substance: identified as aluminum.
Sold states
USA Nationwide
Affected count
11,328 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2025More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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