Class I · High risk
FDA Drug Recalls
150 recalls · Class I, newest first
Class I · High risk
Class I · High risk
Class I · High risk
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL
Non-Sterility
Class I · High risk
Class I · High risk
Class I · High risk
Class I · High risk
Fentanyl-Bupivacaine HCL Pf Injectable 3000mcg-12mg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Lioresal Pf Injectable 7.5mg-1625mcg/Ml
Non-Sterility
Class I · High risk
Bupivacaine Hcl-Baclofen Pf Injectable 40mg-4000mcg/Ml
Non-Sterility
Class I · High risk
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
BD ChloraPrep Clear
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
ChlroraPrep One-Step
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk
ChloraPrep With Tint
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk
BD ChloraPrep Clear 3 mL Applicators
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk
Amikacin Sulfate Injection
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class I · High risk
Prochlorperazine Edisylate Injection
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class I · High risk
Lubrisine eye drops
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class I · High risk
puriton EYE RELIEF DROPS
Non-Sterility: Product manufactured under non-sterile production conditions.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk
Hydromorphone
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk
Hcg 5
Non-Sterility
Class I · High risk
GERICARE Eyewash
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Class I · High risk
Activase (alteplase)
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class I · High risk
Nano PNC Water
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.