FDA Drug Recalls
1,122 recalls, newest first
Class I · High risk Ongoing Oct 31, 2023
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing Oct 31, 2023
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing Oct 31, 2023
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing Oct 31, 2023
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing Oct 31, 2023
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Terminated Oct 31, 2023
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Terminated Oct 31, 2023
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class III · Low risk Terminated Oct 30, 2023
Reason Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated…
Class III · Low risk Terminated Oct 27, 2023
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class III · Low risk Terminated Oct 27, 2023
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class II · Moderate risk Terminated Oct 27, 2023
Reason Failed Dissolution Specifications
Class III · Low risk Terminated Oct 26, 2023
Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class I · High risk Terminated Oct 23, 2023
Reason Failed Content Uniformity Specifications
Class III · Low risk Terminated Oct 23, 2023
Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…
Class II · Moderate risk Ongoing Oct 23, 2023
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class I · High risk Ongoing Oct 20, 2023
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing Oct 20, 2023
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing Oct 20, 2023
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class II · Moderate risk Terminated Oct 20, 2023
Reason Failed Viscosity Specifications: Out-of-specification test results for viscosity
Class II · Moderate risk Ongoing Oct 20, 2023
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Class II · Moderate risk Ongoing Oct 20, 2023
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Class II · Moderate risk Ongoing Oct 20, 2023
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed…
Class II · Moderate risk Ongoing Oct 20, 2023
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing Oct 20, 2023
Reason Sub-potent Drug: Lower potency than labeled.
Class III · Low risk Terminated Oct 20, 2023
Reason Failed Impurities/Degradation Specifications