Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns
Anderson Compounding Pharmacy is recalling 99 vials of HCG 20 Day Extra Strength 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe; while specific injury reports are not detailed in the source, the lack of sterility assurance in an injectable drug represents a significant risk of harm consistent with the Severe tier for Class II drug recalls.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 99 vials of HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial. The product was distributed nationwide. The recall was initiated because of a lack of sterility assurance.
The recalled product is identified as HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, manufactured by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, located at 310 Bluff City Hwy, Bristol, TN. The recall covers all lots of this specific product.
Consumers who possess this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 99
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 · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereHCG Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls HCG Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereUS Compounding Recalls HCG/B12 Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- HighCompounded HCG and B-12 Injection Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23