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

18,003 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Testosterone Cypionate 200 mcg/mL in Corn Oil 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-329-2016
Class II · Moderate risk

Testosterone Cypionate 200 mcg/mL in Sesame Oil 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-328-2016
Class II · Moderate risk

Testosterone Cypionate 50 mg/mL 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-327-2016
Class II · Moderate risk

sermorelin 1000 mcg/mL / LIDO 0.2% 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-326-2016
Class II · Moderate risk

Sermorelin 1000 mcg/mL SUB-Q* 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-325-2016
Class II · Moderate risk

Sermorelin 9 mg/10 mL SUB-Q* 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-324-2016
Class II · Moderate risk

QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / 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-323-2016
Class II · Moderate risk

Progesterone 100 mg/mL Ethyl Oleate 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-322-2016
Class II · Moderate risk

Progesterone 100 mg/mL in Corn Oil 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-321-2016
Class II · Moderate risk

Progesterone 100 mg/mL IM* Injection in Sesame 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-320-2016
Class II · Moderate risk

MIC 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-319-2016
Class II · Moderate risk

Methylcobalamin 30 mg/mL PF 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-318-2016
Class II · Moderate risk

Methylcobalamin 25 mg/mL PF 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-317-2016
Class II · Moderate risk

Methylcobalamin 20 mg/mL PF 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-316-2016
Class II · Moderate risk

Methylcobalamin 5000 mcg/mL Preservative Free 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-315-2016
Class II · Moderate risk

Methylcobalamin 1 mg/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-314-2016
Class II · Moderate risk

LIPO-B Special 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-313-2016
Class II · Moderate risk

LIPO B 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-312-2016
Class II · Moderate risk

Hcg 10

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-311-2016
Class II · Moderate risk

HCG 5000 Units/mL 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-310-2016
Class II · Moderate risk

HCG 3000 Units/mL 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-309-2016
Class II · Moderate risk

HCG 2000 Units/mL 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-308-2016
Class II · Moderate risk

HCG 1000 U/ LIDO 0.2%/mL 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-307-2016
Class II · Moderate risk

HCG 1000 Units/mL SUB-Q 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-306-2016
Class II · Moderate risk

Glycerin Opth Solution

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-305-2016

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