HCG SUB-Q Injection (Essential Wellness) – sterility concerns (2015)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Lot Codes / Batch Numbers
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 09/19/2015
Products Sold
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 09/19/2015
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 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. due to Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026