Class II — Potential Health Hazard

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

HCG 10 Recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Due to Lack of Assurance of Sterility: A recall of...

Name: 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, E
Brand: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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 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.

Quantity: 21 vials and 80 prefilled syringes

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.

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