FDA Drug Recalls
778 recalls, newest first
Class III · Low risk Terminated Apr 15, 2025
Reason Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class II · Moderate risk Terminated Apr 15, 2025
Reason cGMP deviations
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil…
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing Apr 14, 2025
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class II · Moderate risk Ongoing Apr 14, 2025
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing Apr 14, 2025
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing Apr 14, 2025
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing Apr 10, 2025
Reason Subpotent
Class II · Moderate risk Ongoing Apr 10, 2025
Reason Subpotent
Class II · Moderate risk Ongoing Apr 10, 2025
Reason Subpotent
Class II · Moderate risk Ongoing Apr 10, 2025
Reason Subpotent
Class II · Moderate risk Terminated Apr 10, 2025
Reason Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…
Class II · Moderate risk Ongoing Apr 10, 2025
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk Ongoing Apr 9, 2025
Reason Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error…
Class II · Moderate risk Ongoing Apr 9, 2025
Reason CGMP Deviations
Class II · Moderate risk Ongoing Apr 9, 2025
Reason CGMP Deviations
Class II · Moderate risk Ongoing Apr 3, 2025
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit