Class III · Low risk
Clobetasol Propionate Cream
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class II · Moderate risk
VILEVEV MB Urinary Antispetic
cGMP deviations
Class II · Moderate risk
Vilamit Mb
cGMP deviations
Class I · High risk
Born Basic.
Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
LUX EOI Hand Sanitizing Gel
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Born Basic.
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
scent theory KEEP CLEAN Moisturizing Hand Sanitizer
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
scent theory KEEP IT CLEAN
CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class I · High risk
STIMATE (desmopressin acetate)
Superpotent Drug
Class I · High risk
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL
Superpotent Drug
Class I · High risk
DDAVP Nasal Spray
Superpotent Drug
Class II · Moderate risk
Mibelas 24 Fe
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk
Fentanyl Citrate Inj.
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Class II · Moderate risk
HGH Vitality Homeopathic
Labeling: Error on Declared Strength
Class II · Moderate risk
Bersih Hand Sanitizer Gel
cGMP Deviations
Class II · Moderate risk
Lidocaine Patch 5%
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class III · Low risk
Fosaprepitant for Injection
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.