Beacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Alprostadil injection due to FDA inspectional findings regarding quality control and 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. Per the rubric, FDA Class II recalls with potential for significant health consequences (such as sterility failure in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Alprostadil, 50 mcg/ml injection solution. The product is compounded for intravenous and subcutaneous use only and is available in all presentations. The recall covers products distributed nationwide in the United States.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. These findings specifically impacted the assurance of sterility for the compounded medication.
Patients who have received this medication should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Compounded 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 (1)
- 07232013@28
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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 86 products in this recall →Related recalls
Same manufacturer · Beacon Hill Medical Pharmacy, P.C.
See all →- SevereBeacon Hill Medical Pharmacy Recalls B-12 Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- HighBeacon Hill Medical Pharmacy Recalls Sermorelin Acetate Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Potassium Chloride Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Multitrace-5 Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereBeacon Hill Medical Pharmacy Recalls Furosemide Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
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
- SevereFDA Recalls Alprostadil Injectable Solution Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-04
- SevereAlprostadil Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereAlprostadil Injection Recalled for Potential Sterility Issues
FDA (Drugs) · 2015-09-23
- SevereInnovative Compounding Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2020-04-15
- SeverePharm D Solutions Recalls Bi-Mix Injection Due to Sterility Concerns
FDA (Drugs) · 2018-11-07
- SevereAlprostadil Injectable Recall: Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17