Anderson Compounding Pharmacy Recalls HCG 23 Day Vials for Sterility Concerns
Anderson Compounding Pharmacy is recalling HCG 23 Day vials nationwide due to a lack of sterility assurance. Consumers should stop using the product.
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 classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks like sterility issues in injectable products, even without explicit hospitalization reports in the provided text.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 31 vials of HCG 23 Day, 2876 Units/4.6 mL. The recall was initiated because of a lack of sterility assurance in the product. The affected product was distributed nationwide.
The recall covers all lots of the HCG 23 Day vials. The source text does not specify a particular date range or additional distribution details beyond the nationwide scope. The product is a compounded drug manufactured by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 31
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 · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
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
- SevereCompounded HCG Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereUS Compounding Recalls HCG/B12 Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- 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