Class II · Moderate risk
NOREPINEPHRINE 4 mg per 250 mL
Lack of Assurance of Sterility
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
dilTIAZem HCl 125 mg per 125 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class III · Low risk
Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
12 HR Allergy & Congestion Relief Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Relief Allergy Relief D
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Failed dissolution specifications
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Hand Sanitizer Foam
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class II · Moderate risk
Clindamycin and Benzoyl Peroxide Gel
Superpotent Drug
Class II · Moderate risk
Flocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk
Flocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk
Cefixime Capsules 400 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
VANComycin 1g added to 250mL of 0.9% Sodium Chloride
Crystallization: Product appears to be turbid.
Class III · Low risk
Clonidine Transdermal System
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP)
Labelling: Incorrect Exp. Date
Class II · Moderate risk
artnaturals Hand Sanitizer
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot