FDA Recalls HCG 20 Day Injection Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling HCG 20 Day Injection vials nationwide due to a lack of 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (such as infection from lack of sterility) are rated as Severe (4), as they are not Class I but involve a serious health risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for HCG 20 Day Injection, 2625 Units/4 mL, manufactured by Anderson Compounding Pharmacy, Inc. The recall involves 217 vials distributed nationwide. The agency has classified this as a Class II recall.
The reason for the recall is a lack of sterility assurance. This means the product may not be sterile, which poses a risk of infection if administered. The recall covers all lots of the product.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable
- Affected units
- 217
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 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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 68 products in this recall →Related recalls
Same manufacturer · Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
See all →- HighAnderson Compounding Pharmacy Recalls Prostaglandin Vials Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereProstaglandin Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
- SevereEstrone Oil Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
- SevereAnderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereGentamicin Irrigation Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-04-24
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- SevereHCG Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls HCG Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2015-09-23
- SevereCompounded HCG Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23