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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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.
Recall initiated: September 3, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233

by Solutions Rx Pharmacy

Reason: Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
Recall initiated: June 22, 2015
Reported by FDA: November 25, 2015
Distribution: AL, GA, TN, LA

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Drug Recall Terminated Historical recordClass II

Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 16, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

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Drug Recall Terminated Historical recordClass II

MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 16, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

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Drug Recall Terminated Historical recordClass II

Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 16, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

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Drug Recall Terminated Historical recordClass II

Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 16, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

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Drug Recall Terminated Historical recordClass II

Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 16, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: October 16, 2015
Reported by FDA: November 25, 2015
Distribution: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Data last updated: September 27, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.