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.
FDA Drug Recalls
18,003 recalls, newest first
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
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications.