Class II · Moderate risk Terminated
Benzocaine 20%
Reason 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.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Benzocaine 20%
Reason 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 Terminated
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical…
Reason 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 Terminated
Anastrozole SR 1 mg Capsules
Reason 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 Terminated
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg…
Reason 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 Terminated
Anastrozole 0.5 mg Capsules
Reason 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 Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Terminated
Clozapine Tablets USP
Reason Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class II · Moderate risk Terminated
Maximum Strength Zephrex-D
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
Reason GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk Terminated
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel
Reason GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk Terminated
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine
Reason GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk Terminated
Extra Strength PreTAT by TAT BALM Gel
Reason GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk Terminated
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine
Reason GMP Deviations: inadequate manufacturing control processes
Class II · Moderate risk Terminated
ePHEDrine Sulfate In 0.9% Sodium Chloride
Reason Subpotent Drug
Class II · Moderate risk Terminated
Estriol
Reason cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk Terminated
Dutasteride and Tamsulosin HCl Capsules
Reason Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class II · Moderate risk Terminated
Paroxetine Tablets
Reason Presence of Foreign Tablets/Capsules.
Class II · Moderate risk Terminated
Succinylcholine 20 MG/ML INJ
Reason Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Class II · Moderate risk Terminated
Zoloft
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk Terminated
ROCuronium Bromide 10 mg per mL
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL…
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag
Reason Lack Of Assurance Of Sterility.