Class II · Moderate risk
Diphenhydramine HCl Oral Solution
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Calcium Carbonate Oral Suspension
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution 650 mg / 20.3 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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.
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.