Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
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
2% Xylocaine DENTAL with Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
Wecare Calasoothe
cGMP deviations
Class II · Moderate risk
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
cGMP deviations
Class II · Moderate risk
Globe Clotrimazole Cream USP
cGMP deviations
Class II · Moderate risk
Globe Clotrimazole Cream
cGMP deviations
Class II · Moderate risk
Nivagen
cGMP deviations
Class II · Moderate risk
Nivagen
cGMP deviations
Class II · Moderate risk
Dynashield
cGMP deviations
Class II · Moderate risk
Nivagen Pharmaceuticals
cGMP deviations
Class II · Moderate risk
WeCare
cGMP deviations
Class II · Moderate risk
Dynagel
cGMP deviations
Class II · Moderate risk
Wecare Enema
cGMP deviations
Class II · Moderate risk
Dynashield Skin Protectant
cGMP deviations
Class II · Moderate risk
Lanashield Skin Barrier
cGMP deviations
Class II · Moderate risk
Phytonadione Injectable Emulsion
Failed Stability Specifications: Observed OOS results: eg results for colour index
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Class II · Moderate risk
Agebox iKids-Growth
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk
Agebox iKids-Growth
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.