Class II · Moderate risk Ongoing
Spironolactone Tablets
Reason Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
FDA Drug Recalls
2,661 recalls, newest first
Class I · High risk Ongoing
Spironolactone Tablets
Reason Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
Paroex
Reason cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Class I · High risk Ongoing
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray
Reason Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Class II · Moderate risk Ongoing
Zapien Productos Hand Sanitizer Gel Antibacterial
Reason cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk Ongoing
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing
Reason cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk Ongoing
Pentosan Polysulfate
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ll-37
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
High Dose B12
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ghk-Cu
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Thymosin Beta - 4
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Cerebrolysin
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Dsip
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
B12 for Injection
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Nandrolone
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ghrp
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ipamorelin
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Thymosin Alpha
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Bpc-157
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Aod-9604
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Pt-141
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Fgl, 10 Mg/Ml
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Cjc-1295
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.