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

1,464 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2015 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
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
Class II · Moderate risk

DUAL TEST CYP/ENA 1:1 200 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-304-2016
Class II · Moderate risk

Dexamethasone 0.4% Opth Ointment

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-303-2016
Class II · Moderate risk

Cyclosporin 0.1% 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-302-2016
Class II · Moderate risk

BIMIX INJ 30 mg-1 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-301-2016
Class II · Moderate risk

17-Alpha Hydroxyprogesterone 250 mg/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-300-2016
Class II · Moderate risk

17-Alpha Hydroxyprogesterone 250 mg/mL in Castor 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-299-2016
Class II · Moderate risk

Acetylcysteine 10% Oph 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-298-2016
Class II · Moderate risk

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.

Terminated Sterility / contamination Baxter Healthcare Corporation NDC 0338-0049-38 D-1816-2015

Recalls by year