86 recalls · Class I, newest first
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Presence of Particulate Matter: Silicone
Reason Presence of Particulate Matter: Silicone
Reason Presence of Particulate Matter: Silicone
Reason Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product…
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Microbial contamination of Non-Sterile Products
Reason Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial…
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Reason Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Reason Non-Sterility
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product…
Reason 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…
Reason 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…
Reason Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Reason Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and…
Reason Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and…
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA…
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA…