Class I · High risk
Ropivacaine Hydrochloride Injection
Presence of Particulate Matter
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
FentaNYL 500mcg
Lack of Assurance of Sterility
Class II · Moderate risk
Dexonto 0.4%
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Class I · High risk
Male Ultra Pro
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Ultra Armor
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Electro Buzz
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Class I · High risk
Malextra
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Male Ultra
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II · Moderate risk
ChlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk
Wegovy (semaglutide)
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
Kapsin Ointment
CGMP Deviations
Class II · Moderate risk
Hemopropin Ointment
CGMP Deviations
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Class II · Moderate risk
Rocuronium Bromide 50 mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Ketamine HCl 50mg per 5mL
Lack of Assurance of Sterility: Leaking/damaged syringes.