Class III · Low risk Terminated
Acyclovir Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 26 mL Applicator
Reason Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Class III · Low risk Terminated
Evrysdi
Reason Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Class III · Low risk Terminated
Asenapine Sublingual Tablets
Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk Terminated
Asenapine Sublingual Tablets
Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class II · Moderate risk Terminated
Estradiol Transdermal System Delivers 0.0375 mg/day
Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk Terminated
Oxygen
Reason cGMP deviations
Class II · Moderate risk Terminated
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Class III · Low risk Terminated
Dry Eye Test
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Cephalexin for Oral Suspension
Reason Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Class II · Moderate risk Terminated
Betadine
Reason Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Class II · Moderate risk Ongoing
Flurandrenolide Ointment USP
Reason Failed Impurities/Degradation Specifications:
Class I · High risk Ongoing
Ginseng Power 5000 capsule
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I · High risk Ongoing
Premium OrgaZEN 7000 capsule
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class II · Moderate risk Ongoing
Triple SupremeZen Plus 3500
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk Ongoing
PremierZen Black 5000
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk Ongoing
PremierZen Extreme 3000
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk Terminated
Itraconazole Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Imperial Platinum 2000
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing
Burro en Primavera
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing
PremierZen Extreme 3000
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing
Imperial Gold 2000
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Terminated
Riomet
Reason Microbial Contamination of Non-Sterile Product
Class II · Moderate risk Ongoing
Guanfacine Extended-Release Tablets 2 mg
Reason Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate