Class III · Low risk Terminated
Candesartan Cilexetil and Hydrochlorothiazide Tablets
Reason Out-of-specification organic impurity results obtained during routine stability testing.
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
Smart Care HAND SANITIZER
Reason Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Class III · Low risk Terminated
Fluocinonide Ointment USP 0.05%
Reason Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Class I · High risk Terminated
Goldenseal POWDER
Reason Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk Terminated
Cord Care POWDER
Reason Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk Terminated
Happy Ducts Compress
Reason Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Class III · Low risk Terminated
Metformin Hydrochloride Tablets USP
Reason Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class III · Low risk Terminated
Cystaran
Reason Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Class II · Moderate risk Terminated
Riomet ER
Reason CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Class III · Low risk Terminated
Homeopathic Energy Catalyst
Reason Labeling: Product Contains Undeclared API; Incorrect formulation
Class I · High risk Terminated
NP Thyroid 120
Reason Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I · High risk Terminated
NP Thyroid 15
Reason Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class II · Moderate risk Terminated
Nature-Throid 1 GR
Reason CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Class III · Low risk Terminated
Nymalize
Reason Subpotent Drug
Class II · Moderate risk Terminated
Albuterol Sulfate Inhalation Aerosol
Reason Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk Terminated
Phentermine
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk Terminated
Diethylpropion
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk Terminated
Diethylpropion
Reason cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class I · High risk Terminated
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v
Reason Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Class III · Low risk Terminated
Citalopram Oral Solution
Reason Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Class III · Low risk Terminated
Nicotine Gum
Reason Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Class II · Moderate risk Terminated
Buprenorphine Transdermal System 5 mcg/hour
Reason Failed Stability Specifications: Below specification result for buprenorphine release rate.
Class II · Moderate risk Terminated
Eye Itch Relief
Reason CGMP Deviations
Class II · Moderate risk Terminated
bio aaa Alcohol en Gel Antibacterial
Reason CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.