US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

MIC Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-319-2016
Class II · Moderate risk Terminated

Methylcobalamin 30 mg/mL PF Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-318-2016
Class II · Moderate risk Terminated

Methylcobalamin 25 mg/mL PF Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-317-2016
Class II · Moderate risk Terminated

Methylcobalamin 20 mg/mL PF Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-316-2016
Class II · Moderate risk Terminated

Methylcobalamin 5000 mcg/mL Preservative Free Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-315-2016
Class II · Moderate risk Terminated

Methylcobalamin 1 mg/mL

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-314-2016
Class II · Moderate risk Terminated

LIPO-B Special Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-313-2016
Class II · Moderate risk Terminated

LIPO B Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-312-2016
Class II · Moderate risk Terminated

Hcg 10

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-311-2016
Class II · Moderate risk Terminated

HCG 5000 Units/mL Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-310-2016
Class II · Moderate risk Terminated

HCG 3000 Units/mL Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-309-2016
Class II · Moderate risk Terminated

HCG 2000 Units/mL Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-308-2016
Class II · Moderate risk Terminated

HCG 1000 U/ LIDO 0.2%/mL Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-307-2016
Class II · Moderate risk Terminated

HCG 1000 Units/mL SUB-Q Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-306-2016
Class II · Moderate risk Terminated

Glycerin Opth Solution

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-305-2016
Class II · Moderate risk Terminated

DUAL TEST CYP/ENA 1:1 200 mg/mL Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-304-2016
Class II · Moderate risk Terminated

Dexamethasone 0.4% Opth Ointment

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-303-2016
Class II · Moderate risk Terminated

Cyclosporin 0.1% Opth Solution

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-302-2016
Class II · Moderate risk Terminated

BIMIX INJ 30 mg-1 mg/mL Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-301-2016
Class II · Moderate risk Terminated

17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-300-2016
Class II · Moderate risk Terminated

17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-299-2016
Class II · Moderate risk Terminated

Acetylcysteine 10% Oph Solution

Reason 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.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma D-298-2016
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection

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

Baxter Healthcare Corporation NDC 0338-0049-38 D-1816-2015
Class II · Moderate risk Terminated

LIPO B STERILE INJECTION 10 mL

Reason Subpotent Drug: trace amounts of methylcobalamin in compounded drug.

Eagle Pharmacy, Inc. D-1832-2015
Class II · Moderate risk Terminated

Bromfenac Ophthalmic Solution 0.09%

Reason Lack of Assurance of Sterility: Failed preservative effectiveness testing

Apotex Inc. NDC 60505-0595-05 D-0009-2016