Class I · High risk
LEADER brand Dry Eye Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class I · High risk
LEADER brand Lubricant Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Lubricant Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Dry Eye Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Eye Irritation Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
Lubricating Tears Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class III · Low risk
V-FORCE Homeopathic
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class III · Low risk
Lisinopril Tablets USP 20 mg
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class III · Low risk
Buspirone Hydrochloride Tabs USP 10 mg
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
Class III · Low risk
Mycophenolate Mofetil for Oral Suspension
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class I · High risk
Phenytoin Oral Suspension
Failed Content Uniformity Specifications
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Class II · Moderate risk
Ranolazine Extended-Release Tablets 500mg
Failed Dissolution Specifications: Out of specification for dissolution.
Class I · High risk
Kuka Flex Forte caplets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk
Reumo Flex caplets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk
Artri King Reforzado con Origa y Omega 3 tablets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class II · Moderate risk
Tiglutik (riluzole)
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Class II · Moderate risk
Equate Hand Sanitizer
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk
DOP Instant Hand Sanitizer
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk
DOP Instant Hand Sanitizer
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk
Deferasirox Tablets for Oral Suspension
Failed Dissolution Specifications
Class III · Low risk
Oxaydo (oxycodone HCl, USP)
Sub-potent Drug: Lower potency than labeled.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Failed Impurities/Degradation Specifications