Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
What this means for you
Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a significant risk of harm (sterility failure in an injectable drug) corresponds to a severity score of 4 (Severe), particularly given the potential for serious injury from non-sterile injections.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection, 40MCG/30MG/2MG/ML, 2.5 mL Multi-dose Vial. The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by Lot # 11112019+53214 with an expiration date of 3/5/2020. The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.
This is a prescription-only medication intended for intracavernosal use. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2
- Category
- Drug — Injectable
- Hazard
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 #: 11112019+53214
- Exp 3/5/2020
Distribution
Part of a larger recall action
This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical 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 63 products in this recall →Related recalls
Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
See all →- Severe
- SevereAxia Pharmaceutical Recalls Selenium Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- Severe
- SevereAxia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
- SevereAxia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns
FDA (Drugs) · 2020-03-11
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15