Class III · Low risk
Bull Capsules
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class II · Moderate risk
All sterile drug preparations remaining within expiry prepared…
Lack of sterility assurance.
Class I · High risk
BLUE PEARL capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class II · Moderate risk
Valsartan Tablets
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Class III · Low risk
Penicillin V Potassium for Oral Solution
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class II · Moderate risk
Vertra Elemental Resistance
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Class III · Low risk
Duloxetine Delayed-Release Capsules USP
Failed Dissolution Specification
Class II · Moderate risk
Glenmark Mometasone Furoate Cream
CGMP Deviations: Market complaints related to "gritty texture".
Class II · Moderate risk
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg)
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Class II · Moderate risk
Paroxetine Tablets USP
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Class I · High risk
Hard Times For Men capsules
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class II · Moderate risk
Pravastatin Sodium USP
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Class II · Moderate risk
7-Keto DHEA 25mg Capsule
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
7-Ketodehydroepiandrosterone
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Vitamin 10 B Lyophilized Vial
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Vitamin 9 A/B Lyophilized Vial
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Vitamin 9 Lyophilized Vial
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL)
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Trimix #23F
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Trimix #22F
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.