Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HCG 1000 Units/mL SUB-Q Injection Recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Due to Lack of Assurance of Sterility: A recall of...

Date: September 3, 2015
Company: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Kalman Health & Wellness, Inc. dba Essential Wellness Pharma directly.

Affected Products

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.

Quantity: 49 vials

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma has 39 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report