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Stop using now Drug recall · FDA · Published September 3, 2015

Essential Wellness Pharma Recalls Progesterone Injections Due to Sterility Risk

Essential Wellness Pharma recalls Progesterone 100 mg/mL injections due to lack of sterility assurance. Check lot #072915.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-321-2016DrugEssential Wellness Pharma ›
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Contact the company

Recalling firmKalman Health & Wellness, Inc. dba Essential Wellness Pharma4625 N University St · Peoria, IL 61614-5828
✎ GovInfoNow plain-language explainer

What happened, in plain English

Essential Wellness Pharma is recalling all compounded sterile preparations within their expiry date because of poor sterile production practices that resulted in a lack of sterility assurance for their finished drugs. The specific recalled item identified in the record is Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials (Lot #072915, Exp 10/29/2015). Because the sterility of these injections cannot be assured, there is a risk that the product may not be free from viable microorganisms. The recall was initiated on September 3, 2015, and distribution was nationwide. Read more at govinfonow.com/recall/43741-kalman-health-wellness-inc-dba-essential-wellness-pharma-recalls-progesterone.

Source Summary by GovInfoNow · govinfonow.com/recall/43741-kalman-health-wellness-inc-dba-essential-wellness-pharma-recalls-progesterone · Updated October 12, 2026 · FDA enforcement record: FDA #D-321-2016

Cite this page

“Essential Wellness Pharma Recalls Progesterone Injections Due to Sterility Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43741-kalman-health-wellness-inc-dba-essential-wellness-pharma-recalls-progesterone. Based on FDA recall #D-321-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-321-2016%22&limit=1).

Why it’s dangerous

The recall is due to observations associated with poor sterile production practices, which resulted in a lack of sterility assurance for the finished drugs. Injecting a product that lacks sterility assurance can introduce viable microorganisms into the body, potentially leading to serious infections or other adverse health events.

Who’s affected

Patients who have been prescribed or received Progesterone 100 mg/mL in Corn Oil Injection from Essential Wellness Pharmacy. Individuals with this specific lot number are at risk of exposure to non-sterile product.

How to tell if you have this one

Look for Progesterone 100 mg/mL in Corn Oil Injection in 2 mL vials, Rx only. Check if it was dispensed by Essential Wellness Pharmacy at 4625 N. University, Peoria, IL 61614. Specifically check the lot number #072915 with an expiration date of 10/29/2015.

  • Brand
    Essential Wellness Pharma
  • Category
    Drug
FDA recall event · 39 products

All 39 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide
Recall numberProduct, codes & lotsQuantity
D-298-2016Acetylcysteine 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.; Lot #: 2839-081715, Exp 11/17/20152 dropper bottles
D-299-201617-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 062015, Exp 09/20/2015; 062215, Exp 09/22/2015; 062515, Exp 09/25/2015; and 072115, Exp 10/21/20154 vials
D-300-201617-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 060815, Exp 09/08/2015; 062915, Exp 09/29/2015; 072315, Exp 10/23/2015; and 760-081815, Exp 11/18/201535 vials
D-301-2016BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 071015, Exp 09/10/2015; 072115, Exp 09/21/2015; and 080715, Exp 10/07/20155 vials
D-302-2016Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 062915, Exp 09/29/2015; 070915, Exp 10/09/2015; 073015, Exp 10/30/2015; 080315, Exp 11/03/2015; and 080615, Exp 11/06/20157 dropper bottles
D-303-2016Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 062515, Exp 09/25/2015; and 070615, Exp 10/06/20152 ointment tubes
D-304-2016DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 062915, Exp 09/29/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; 073015, Exp 10/30/2015; and 080615, Exp 11/08/2015a) 720 vials; b) 4 vials
D-305-2016Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 071515, Exp 10/15/20151 dropper bottle
D-306-2016HCG 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.; Lot #: 080415, Exp 09/04/2015; 080515, Exp 09/05/2015; 080615, Exp 09/06/2015; 080715, Exp 09/07/2015; 081015, Exp 09/10/2015; 081115, Exp 09/11/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/14/2015; 1702-081715, Exp 09/17/2015; 1702-081815, Exp 09/18/2015; and 1702-081915, Exp 09/19/201549 vials
D-307-2016HCG 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.; Lot #: 080415, Exp 09/04/2015; and 4721-081715, Exp 09/17/20152 vials
D-308-2016HCG 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.; Lot #: 080415, Exp 09/04/2015; and 080715, Exp 09/07/20152 vials
D-309-2016HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 081015, Exp 09/10/20151 vial
D-310-2016HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 081315, Exp 09/13/20151 vial
D-311-2016HCG 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.; Lot #: 080615, Exp 09/06/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/14/2015; 1730-081715, Exp 09/17/2015; 1730-081815, Exp 09/18/2015; and 1730-081915, Exp 09/19/201521 vials and 80 prefilled syringes
D-312-2016LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 061215, Exp 09/12/2015; 061915, Exp 09/19/2015; 070115, Exp 10/01/2015; 072315, Exp 10/23/2015; and 073115, Exp 10/31/201576 vials
D-313-2016LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 073115, Exp 10/31/20151 vial
D-314-2016Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 072915, Exp 09/13/2015; 080415, Exp 09/19/2015; and 1345-081815, Exp 10/03/201510 prefilled syringes
D-315-2016Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 072715, Exp 09/10/2015; and 073015, Exp 09/13/20152 vials
D-316-2016Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 3327-081715, Exp 09/17/201528 prefilled syringes
D-317-2016Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 072915, Exp 09/13/20158 prefilled syringes
D-318-2016Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 072815, Exp 09/10/201530 prefilled syringes
D-319-2016MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 071315, Exp 10/13/20151 vial
D-320-2016Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 062315, Exp 09/23/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/201550 vials
D-321-2016Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 072915, Exp 10/29/20151 vial
D-322-2016Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 072415, Exp 10/24/2015; and 080715, Exp 11/07/20152 vials
D-323-2016QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 071315, Exp 09/13/20151 vial
D-324-2016Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 080515, Exp 09/05/2015; 080715, Exp 09/07/2015; 081115, Exp 09/11/2015; and 081415, Exp. Date 09/14/20157 vials
D-325-2016Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 080415, Exp 09/04/2015; 080515, Exp 09/05/2015; 080615, Exp 09/06/2015; 080715, Exp 09/07/2015; 081015, Exp 09/10/2015; 081115, Exp 09/11/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/13/2015; 081515, Exp 09/15/2015; 453-081715, Exp 09/17/2015; 453-081815, Exp 09/18/2015; and 453-081915, Exp 09/19/201564 vials
D-326-2016sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 080415, Exp 09/04/20152 vials
D-327-2016Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 081215, Exp 11/12/20155 vials
D-328-2016Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/2015261 vials
D-329-2016Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 070115, Exp 10/01/2015; and 071015, Exp 10/10/20152 vials
D-330-2016Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 062915, Exp 09/29/2015; and 071615, Exp 10/16/201520 vials
D-331-2016Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 060415, Exp 09/04/20151 vial
D-332-2016TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 071015, Exp 09/10/2015; 071715, Exp 09/17/2015; and 073015, Exp 09/30/20156 vials
D-333-2016TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot # 070815, Exp 09/08/2015; 071715, Exp 09/17/2015; 073115, Exp 10/012015; 080415, Exp 10/04/2015; and 080615, Exp 10/06/20155 vials
D-334-2016TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 070915, Exp 09/09/2015; and 080315, Exp 10/03/20152 vials
D-335-2016TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 070715, Exp 09/07/20151 vial
D-336-2016TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.; Lot #: 073115, Exp 10/01/20151 vial
Based on the official FDA remedy

What to do — step by step

  1. Stop using the product

    Do not use any Progesterone injections from this recall, particularly those within their expiry date due to sterility concerns.

  2. Contact your pharmacy

    Reach out to Essential Wellness Pharmacy or your healthcare provider to discuss alternatives and proper disposal of the recalled vials.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Sep 3, 201512. FDA classified it Class II: Nov 17, 201523. Published in FDA’s Enforcement Report: Nov 25, 201534. FDA terminated the recall: Dec 29, 2017420152017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-321-2016 (September 3, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-321-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA