Class I · High risk Terminated
Nature Throid
Reason Subpotent Drug: FDA analysis found product to be subpotent
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
WP Thyroid
Reason Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk Terminated
Goldenseal Root Powder Organic
Reason Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Class I · High risk Terminated
Tranexamic Acid Injection
Reason Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I · High risk Terminated
Amiodarone Hydrochloride Injection
Reason Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I · High risk Terminated
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing…
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
Florance Morris ANTISEPTIC Hand Sanitizer
Reason Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Class I · High risk Terminated
Volu-Sol Handrub Sanitizing Solution
Reason Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Class I · High risk Terminated
Incredible Products Gelbac T Antibacterial Hand Gel
Reason Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Class I · High risk Terminated
Heparin Sodium 10
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk Terminated
Heparin Sodium 5
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk Terminated
Heparin Sodium 5
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk Terminated
Heparin Sodium 2
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk Terminated
Herbacil
Reason Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
Class I · High risk Terminated
Born Basic.
Reason 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 I · High risk Terminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Reason Cross Contamination with other products: trace amounts of lidocaine
Class I · High risk Terminated
Stimate
Reason Superpotent Drug
Class I · High risk Terminated
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL
Reason Superpotent Drug
Class I · High risk Terminated
DDAVP Nasal Spray
Reason Superpotent Drug
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Class I · High risk Terminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer
Reason Chemical Contamination: Products contain methanol and were below the label claim for ethanol content