Class II · Moderate risk Ongoing
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia…
Reason Presence of foreign substance: identified as aluminum.
Is Spironolactone recalled?
11 FDA recalls mention Spironolactone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Spironolactone.
Class II · Moderate risk Terminated
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc…
Reason Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Class I · High risk Ongoing
Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC…
Reason Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Class II · Moderate risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY…
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I · High risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at…
Reason Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Class II · Moderate risk Terminated
All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Spironolactone 5 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc…
Reason Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting…
Class II · Moderate risk Terminated
Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1
Reason Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting…
Class II · Moderate risk Terminated
Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC…
Reason Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting…
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