Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Presence of Particulate Matter: identified as glass.
Presence of Particulate Matter: identified as glass.
Presence of Particulate Matter: identified as glass.
Microbial contamination of Non-Sterile Products
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Non-Sterility
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Chemical Contamination: FDA testing found Presence of methanol
Chemical Contamination: FDA testing found Presence of methanol
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Non-Sterility