Class II · Moderate risk
Acetaminophen Oral Solution 160 mg / 5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Magnesium Hydroxide 2400 mg
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Magnesium Hydroxide 1200 mg
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I · High risk
Magnesium Hydroxide 2400 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Magnesium Hydroxide 1200 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
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
Testosterone Cypionate Injection
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class II · Moderate risk
Testosterone Cypionate Injection
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
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.
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
Artri King Reforzado con Ortiga Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class II · Moderate risk
Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class I · High risk
Artri King Reforzado con Ortiga Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
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