Class II · Moderate risk
Fludrocortisone Acetate Tablets
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
Infla-650 Herbal Dietary Supplement
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class II · Moderate risk
buPROPion Hydrochloride Extended-release Tablets USP
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II · Moderate risk
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Class II · Moderate risk
Oatmeal Daily Moisturizing Body Lotion
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
Class II · Moderate risk
Potassium Chloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Potassium Chloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
suntegrity
CGMP Deviations
Class II · Moderate risk
Dexamethasone Sodium Phosphate injection USP
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Class II · Moderate risk
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Lack of Assurance of Sterility: Leaking vials
Class II · Moderate risk
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class II · Moderate risk
Extra Strength Acetaminophen 500 MG Tablets
Discoloration: Brownish tablets
Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.