Class II · Moderate risk
Carvedilol 25 mg
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Class II · Moderate risk
Sodium Phenylbutyrate POWDER
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Carvedilol Tablets
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Class II · Moderate risk
Sodium Selinite 200mcg/Ml for Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Progesterone 100mg/Ml Mdv Oil Injection
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mit/B12 25/50/50mg/Ml 1mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a/B6 15/50/100 5mg/50mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a 25/50/50mg/Ml 1mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic 25/50/50mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 5000mcg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 12.5mg/Ml Mdv Inj Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 1000mcg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 10
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Folic Acid 10mg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Calcium Gluconate 10% Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Benzalkonium Chloride 0.013% Solution
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Acetylcysteine 2% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Acetylcysteine 10% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Vit B Complex Inj Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Vit B Complex Inj Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns