Class III · Low risk Ongoing
Fesoterodine Fumarate
Reason Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
FDA Drug Recalls
2,661 recalls, newest first
Class III · Low risk Ongoing
Everolimus tablets 2.5 mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk Ongoing
Everolimus tablets 10 mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk Ongoing
Everolimus tablets 7.5mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class III · Low risk Ongoing
Everolimus tablets 5mg
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Class II · Moderate risk Ongoing
R.E.C.K.
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Hadlima
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing
Niacin Extended-release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Gabapentin Capsules
Reason Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Class II · Moderate risk Ongoing
Taoscare Motion Sickness Patches 36-count box
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Ongoing
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %
Reason Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Class II · Moderate risk Ongoing
Sucralfate Tablets
Reason CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class III · Low risk Ongoing
FentaNYL Citrate PF
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Ongoing
Ketamine Hydrochloride
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Ongoing
Hydromorphone HCL PF
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class I · High risk Ongoing
Mojo Max Fusion XXX
Reason Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
Class II · Moderate risk Ongoing
Fasenra
Reason Lack of Assurance of Sterility:
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride
Reason CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II · Moderate risk Ongoing
Carbidopa
Reason Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II · Moderate risk Ongoing
Desipramine Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing
Desipramine Hydrochloride Tablets
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.