Essential Wellness Pharma Recalls Testosterone Injection Vials Due to Sterility Concerns
Kalman Health & Wellness is recalling 20 vials of Testosterone Injection due to poor sterile production practices that compromised sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility failures in injectable drugs are categorized as Severe.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 20 vials of Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6 mg/66.6 mg/mL, 5 mL vials. The affected lots are 062915 (Exp 09/29/2015) and 071615 (Exp 10/16/2015). The product was distributed nationwide.
The recall was initiated because of observations associated with poor sterile production practices. These practices resulted in a lack of sterility assurance for the finished compounded sterile preparations.
Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Testosterone 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.
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 062915
- Exp 09/29/2015
- and 071615
- Exp 10/16/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 39 products in this recall →Related recalls
Same manufacturer · Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
See all →- SevereEssential Wellness Pharma Recalls BIMIX INJ Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereEssential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections for Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereEssential Wellness Pharma Recalls Sermorelin Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- Severe
- SevereEssential Wellness Pharma Recalls Dexamethasone Ointment Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereGreen Valley Drugs Recalls Testosterone Injections Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- HighQualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-12-02
- SevereUS Compounding Recalls Testosterone Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereAuro Pharmacies Recalls Testosterone Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
- HighTestosterone Enanthate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereAuro Pharmacies Recalls Testosterone Cypionate/Enanthate Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-09-05