Class II · Moderate risk
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
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70
cGMP Deviations
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45
cGMP Deviations
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30
cGMP Deviations
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70
cGMP Deviations
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray SPF 30
cGMP Deviations
Class II · Moderate risk
Class I · High risk
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath)
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
Class II · Moderate risk
QiYu Hand Sanitizer
Subpotent
Class II · Moderate risk
Compounded Lyophilized AOD-9604
Lack of Assurance of Sterility
Class II · Moderate risk
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Lack of Assurance of Sterility
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance- Potential of metal contamination.
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class II · Moderate risk
NIFEdipine EXTENDED-RELEASE TABLETS
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk
MIC+Methyl B12 injection Methionine Inositol…
Lack of processing controls
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk
Xylocaine-MPF with Epinephrine 1:200
Low out of specification results for epinephrine assay.