Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

18,003 recalls, newest first

Class II · Moderate risk

Dex LA 8 (Dexamethasone acetate (8 mg/mL)

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3299-02 D-0248-2016
Class II · Moderate risk

Dapiprazole

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-0201-99 D-0247-2016
Class II · Moderate risk

Cyclopent/PE/Tropic 2mL

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3299-02 D-0246-2016
Class II · Moderate risk

Cyclo/PE/Tropic/Ketor

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3044-07 D-0245-2016
Class II · Moderate risk

Cyclo/PE/Trop PF

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3049-03 D-0244-2016
Class II · Moderate risk

Brompheniramine Maleate

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3019-07 D-0243-2016
Class II · Moderate risk

Betamethasone SP PF

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3016-02 D-0241-2016
Class II · Moderate risk

Betamethasone SP

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3240-07 D-0240-2016
Class II · Moderate risk

Betamethasone Combo PF 2 mL

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3018-02 D-0239-2016
Class II · Moderate risk

Betamethasone Combo 10 mL

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc NDC 62295-3018-10 D-0238-2016
Class II · Moderate risk

Alprostadil

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc D-0237-2016
Class II · Moderate risk

Acetylcysteine 10% Ophtalmic

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Terminated Sterility / contamination US Compounding Inc D-0236-2016
Class III · Low risk

ClomiPHENE CITRATE Tablets

Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.

Terminated Chemical / undeclared EMD Serono, Inc. NDC 0093-0041-03 D-1813-2015
Class II · Moderate risk

Fenoglide (fenofibrate)

Failed Dissolution Specifications: Failed 24 month dissolution testing.

Terminated Dissolution failure Valeant Pharmaceuticals North America LLC D-0163-2016
Class II · Moderate risk

Trimix Special

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Terminated Sterility / contamination Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-336-2016
Class II · Moderate risk

TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL)

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Terminated Sterility / contamination Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-335-2016
Class II · Moderate risk

TRIMIX #3 (24 mg-1 mg-20 mcg/mL)

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Terminated Sterility / contamination Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-334-2016
Class II · Moderate risk

TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL)

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Terminated Sterility / contamination Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-333-2016
Class II · Moderate risk

TRIMIX #1 Injection

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Terminated Sterility / contamination Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-332-2016
Class II · Moderate risk

Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Terminated Sterility / contamination Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-331-2016
Class II · Moderate risk

Testosterone CYP/ENAN/PROP Injection

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Terminated Sterility / contamination Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-330-2016

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