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chorionic gonadotropin (hcg) FDA Alerts

The FDA Alert(s) below may be specifically about chorionic gonadotropin (hcg) or relate to a group or class of drugs which include chorionic gonadotropin (hcg).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for chorionic gonadotropin (hcg)

HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance

Feb 15, 2017

Audience: Consumer

[Posted 02/15/2017]

ISSUE: Synergy Rx Pharmacy recalled all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a lack of sterility assurance. This recall impacts all sterile products distributed between 06/01/2016 and 12/22/2016. The product was only distributed to physician offices and clinics in Arizona, California, Wisconsin, and Minnesota.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

BACKGROUND: Human Chorionic Gonadotropin (HCG) is an unapproved product marketed for weight loss. The product is packaged in 15 mL serum glass vials bearing a label that includes Synergy Rx Pharmacy’s name and expiration date. All lots of these products are affected. Synergy Rx Pharmacy has not received any reports of adverse events, to date, related to this recall.

RECOMMENDATION: Synergy Rx Pharmacy is notifying its customers by phone and is arranging for return of all recalled products. Customers that have the recalled product should immediately stop using it and contact the help line to arrange for the return of any unused product.

Customers with questions regarding this recall can contact Synergy Rx Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm Pacific Time Zone, at 619-821-8224.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[02/14/2017 - Press Release - Synergy Rx Pharmacy]

HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance

Jul 22, 2016

Audience: Patient, Pharmacy

ISSUE: Talon Compounding Pharmacy (TCP) voluntarily recalled all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to FDA concern over a lack of sterility assurance. Administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.

The sterile products were distributed to patients and providers nationwide between January 18 and July 18, 2016.

BACKGROUND: The recalled lots were packaged in 10ml amber glass vials bearing a label containing the name and strength of the drug, the lot number and the beyond-use date.

RECOMMENDATION: Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. Providers who have dispensed any lyophilized HCG or sermorelin to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall. Talon is asking all patients and providers that received lyophilized HCG and sermorelin compounded products from TCP between January 18 and July 18, 2016, and that remain within expiry, to take the following actions:

  • Discontinue use of the products;
  • Quarantine any unused product until further instructions are received on how to return the product; and
  • Contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at talonrecall@gmail.com to discuss the return of any unused lyophilized HCG and/or sermorelin.

Customers with questions regarding this recall can contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at talonrecall@gmail.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/22/2016 - Press Release - FDA]

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