Class III · Low risk
Peg-3350
Defective container: potential for non-sealed pouches which can lead to product leakage.
FDA Drug Recalls
76 recalls · Class III, newest first
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class III · Low risk
Sevelamer Carbonate for Oral Suspension 0.8g packets
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Nature's Script CBD Cryotherapy Pain Relief Roll on
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Diflorasone Diacetate Ointment
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class III · Low risk
SinuFrin Decongestant
Sub-potent Drug
Class III · Low risk
Dodex Injectable
Subpotent drug: out of specification results
Class III · Low risk
Eszopiclone Tablets
Failed Impurities/Degradation Specifications: Related Substances
Class III · Low risk
Complete 30C/200C Homeopathic Kit
Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Eptifibatide injection 20mg/10mL
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class III · Low risk
Tivicay PD
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
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.
Class III · Low risk
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.
Class III · Low risk
Pregabalin Capsules 50mg
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
Cephalexin for Oral Suspension
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
Cephalexin for Oral Suspension
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'