Synergy Rx Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
Synergy Rx is recalling 1,809 vials of Human Chorionic Gonadotropin (HCG) because the product lacks assurance of sterility and has CGMP deviations.
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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Synergy Rx is recalling 1,809 vials of Human Chorionic Gonadotropin (HCG) in 5,000 units/vial and 11,000 units/vial strengths. The recall covers all lots of the prescription-only medication, which was distributed nationwide within the United States.
The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. These issues indicate that the manufacturing process did not meet required standards for ensuring the product is sterile.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments or next steps.
The recalled product
- Product
- Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,809
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by Synergy Rx 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 81 products in this recall →Related recalls
Same manufacturer · Synergy Rx
See all →- SevereSynergy Rx Recalls Lidocaine Creams Due to Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
- HighSynergy Rx Recalls Ultra Lite Cream Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Recalls Lactic Acid Solution Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- HighSynergy Rx Modified Jessner Peel Recalled for Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-03-22
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SeverePharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns
FDA (Drugs) · 2019-06-19
- SevereKRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SeverePharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
- SevereGreen Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns
FDA (Drugs) · 2013-05-22
- SeverePharm D Solutions Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
FDA (Drugs) · 2018-12-26
- SevereAxia Pharmaceutical Recalls hCG Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11