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

1,711 recalls, newest first

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
Class II · Moderate risk

Blephamide

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0313-04 D-1820-2015
Class II · Moderate risk

FML (fluorometholone ophthalmic ointment)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0316-04 D-1819-2015
Class II · Moderate risk

Refresh P.M.

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0240-04 D-1818-2015
Class II · Moderate risk

Refresh Lacri-Lube

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0312-04 D-1817-2015

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