Class II · Moderate risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class I · High risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class I · High risk
Nifedipine WSP 0.2% Ointment
Subpotent and Superpotent Drug
Class II · Moderate risk
Hydrogen Peroxide Topical Solution
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP - Water leakage
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class III · Low risk
Mometasone Furoate
Defective Container
Class II · Moderate risk
70% ISOPROPYL ALCOHOL First aid antiseptic
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Class I · High risk
CVS Health Magnesium Citrate SALINE LAXATIVE
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class I · High risk
Arti King Refozado con Ortiga y Omega 3 Tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg per suppository
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg capsules
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection