Class II · Moderate risk
WeCare
cGMP deviations
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
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.
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
0.9% SODIUM CHLORIDE Injection
Lack of Assurance of Sterility: Potential for flexible container leaks.
Class II · Moderate risk
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk
Bromocriptine Mesylate Capsules
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk
Tylenol
Defective Container