Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Ongoing
Nature's Script CBD Cryotherapy Pain Relief Roll on
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Hemp Bombs CBD Pain Freeze
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk Ongoing
Diflorasone Diacetate Ointment
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class III · Low risk Ongoing
SinuFrin Decongestant
Reason Sub-potent Drug
Class III · Low risk Terminated
Dodex Injectable
Reason Subpotent drug: out of specification results
Class III · Low risk Ongoing
Eszopiclone Tablets
Reason Failed Impurities/Degradation Specifications: Related Substances
Class III · Low risk Terminated
Complete 30C/200C Homeopathic Kit
Reason Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class III · Low risk Ongoing
Asmanex Twisthaler
Reason Defective Container
Class III · Low risk Ongoing
Asmanex Twisthaler
Reason Defective Container
Class III · Low risk Ongoing
Asmanex Twisthaler
Reason Defective Container
Class III · Low risk Ongoing
Eptifibatide injection 20mg/10mL
Reason Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class III · Low risk Terminated
Tivicay PD
Reason Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III · Low risk Ongoing
Estradiol Transdermal System
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Ongoing
Estradiol Transdermal System
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Ongoing
Pregabalin Capsules 50mg
Reason Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Class III · Low risk Ongoing
Sirolimus Tablets 1mg Tablets 100-count bottle
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Completed
Fentanyl 1000mcg/100mL
Reason Labeling: Wrong Barcode
Class III · Low risk Completed
Valacyclovir Tablets USP
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class III · Low risk Terminated
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Reason Subpotent drug