Class I · High risk Ongoing
Electro Buzz
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
FDA Drug Recalls
2,661 recalls, newest first
Class I · High risk Ongoing
Malextra
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
Male Ultra
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
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk Ongoing
ChlorproMAZINE Hydrochloride Tablets
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent
Class II · Moderate risk Ongoing
Testosterone Cypionate Injection
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk Ongoing
Wegovy
Reason Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Class II · Moderate risk Ongoing
Kapsin Ointment
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Hemopropin Ointment
Reason CGMP Deviations
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Ongoing
Haloperidol Decanoate Injection
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk Ongoing
Rocuronium Bromide 50 mg per 5mL
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
Ketamine HCl 50mg per 5mL
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
PHENYLephrine HCl in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
dexmedeTOMIDine HCl PF
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
Glycopyrrolate
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Ongoing
0.9% Sodium chloride Irrigation USP
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Unisom
Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit