Apothecary Shoppe Recalls HCG Injection Due to Sterility Documentation Issues
The Apothecary Shoppe is recalling HCG 1000 U/mL Injection vials because proper environmental monitoring documentation was missing during production.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a documentation issue regarding environmental monitoring rather than a confirmed contamination or reported illness, fitting the criteria for a moderate risk or voluntary precautionary recall.
Plain-English summary
The Apothecary Shoppe LLC is recalling S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vials. The recall involves 98 mL of product with Lot # 04302015@66 and a Beyond Use Date of 06/29/2015. The product was distributed in Oklahoma.
The recall was initiated due to a lack of assurance of sterility. The company identified that proper environmental monitoring documentation was missing during the time the medication was produced. This documentation gap prevents verification that the product was manufactured in a sterile environment.
Consumers who have this specific lot of HCG injection should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Injectable
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 (2)
- Lot #: 04302015@66
- BUD 06/29/2015
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 28 recalled by The Apothecary Shoppe LLC 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 28 products in this recall →Related recalls
Same manufacturer · The Apothecary Shoppe LLC
See all →- SevereThe Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns
FDA (Drugs) · 2016-10-12
- SevereApothecary Shoppe Recalls Phenotolamine and Prostaglandin Vials Due to Sterility Concerns
FDA (Drugs) · 2016-10-12
- SevereMethylcobalamin Injection Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2016-10-12
- ModerateApothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
FDA (Drugs) · 2015-08-12
- ModerateApothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns
FDA (Drugs) · 2015-08-12
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
- SevereHCG Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereAnderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereHCG Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled for Potential Sterility Issues
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls HCG Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2015-09-23