Class I · High risk Terminated
Phenobarbital Tablets USP
Reason Labeling: Label Mixup; potentially mislabeled
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
Phenobarbital Tablets USP
Reason Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Class III · Low risk Terminated
IC-Green
Reason Product is being recalled due to low pH value.
Class II · Moderate risk Terminated
Estradiol 6 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 10 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 12.5 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 15 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 18 mg pellet
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 20 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 22 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Estradiol 25 mg pellet 99.5% Estradiol USP
Reason CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk Terminated
Shield and Protect Moisture Barrier Cream
Reason GMP Deviations; product may not meet cGMP requirements
Class I · High risk Terminated
LabidaMAX Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ZRECT for Women Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ENHANCEROL Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
TORNADO Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
RECTALIS Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
Xrect Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
ZRECT Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
Cummor Natural Male Enhancement
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk Terminated
UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class III · Low risk Terminated
Children's Cetirizine Hydrochloride Chewable Tablets
Reason Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Class II · Moderate risk Terminated
Vitamin D3 in Olive Oil Sdv 100
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.