Class I · High risk
Artri King Reforzado con Ortiga y Omega 3 tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
FDA Drug Recalls
1,018 recalls, newest first
Class I · High risk
Ortiga mas Ajo Rey Reforzado con Omega 3
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk
Artri Ajo King Reforzado con Ortiga y Omega 3 tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class II · Moderate risk
Earache Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Ear Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
B-Complex + Chromic Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Ethanol for Injection 95%
Lack of Assurance of Sterility
Class I · High risk
Tegsedi (inotersen)
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class III · Low risk
Alprostadil Injection USP 500 mcg/mL
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 30 Units/500 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl Injection
Lack of Assurance of Sterility