Class II · Moderate risk
Trokendi XR
Superpotent Drug: Failure of assay specifications in the capsule.
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
Class II · Moderate risk
Dextroamphetamine Sulfate Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Acetylcyst 10% OPHT SOL
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Class II · Moderate risk
Metronidazole 500mg Tablet
CGMP Deviations
Class II · Moderate risk
Doxycycline100mg Tablets
CGMP Deviations
Class II · Moderate risk
Acyclovir 400mg Tablet
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Atorvastatin Calcium 40mg Tablet
CGMP Deviations
Class II · Moderate risk
Acetaminophen 325mg tablets
CGMP Deviations
Class II · Moderate risk
Oxygen Nasal Wash
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Class II · Moderate risk
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on…
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Glipizide 2.5 mg Extended-release tablets
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Class II · Moderate risk
TESTOSTERONE CYPIONATE 200mg/ml
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Class III · Low risk
DULOXETINE Delayed-Release Capsules
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets USP
Failed Dissolution Specifications