Class I · High risk
maXXzen Platinum 12000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
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 I · High risk
PremierZEN Platinum 8000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
PremierZEN Gold 7000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class II · Moderate risk
Diflorasone Diacetate Ointment USP
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class III · Low risk
Readyprep Chg
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class II · Moderate risk
Native Fluoride Toothpaste for Sensitive Teeth
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Class III · Low risk
Sirolimus Tablets 1 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I · High risk
MEDICALLY MINDED Hand Sanitizer Gel
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk
MEDICALLY MINDED Hand Sanitizer Gel
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I · High risk
C-Progesterone Oil 100 Mg/Ml
Non-Sterility
Class I · High risk
Poseidon Platinum 3500 capsule
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class II · Moderate risk
Advance Hand Sanitizer
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
ProtectoRx
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
DiBAR LABS Hand Sanitizer
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I · High risk
DiBAR LABS Hand Sanitizer
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Class II · Moderate risk
Imperia Elita Vitaccino Coffee
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent and Presence of Particulates .
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of foreign substance: identified as activated carbon.