Teva Pharmaceuticals USA recalls Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals
Teva Pharmaceuticals recalls Alprostadil Injection USP 500 mcg/mL vials due to impurities detected in stability testing. This may cause serious injury if used improperly.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals is recalling Alprostadil Injection USP 500 micrograms/mL vials because impurities were found during routine stability testing. Using these vials could lead to serious injury if the product is not handled correctly. Read more at govinfonow.com/recall/39547-teva-alprostadil-injection-recall-impurities-risk-serious-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/39547-teva-alprostadil-injection-recall-impurities-risk-serious-injury · Updated October 6, 2026 · FDA enforcement record: FDA #D-0244-2019
Cite this page
“Teva Alprostadil Injection Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39547-teva-alprostadil-injection-recall-impurities-risk-serious-injury. Based on FDA recall #D-0244-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0244-2019%22&limit=1).
Why it’s dangerous
The product failed impurities and degradation tests during routine stability testing. This means the medication may contain harmful substances that could cause serious injury if used improperly.
Who’s affected
People with prescriptions for Alprostadil Injection USP 500 micrograms/mL 1 mL vials from Teva Pharmaceuticals. Those using the product for erectile dysfunction or other medical conditions are most at risk.
How to tell if you have this one
Check for vials labeled 'Alprostadil Injection USP 500 micrograms/mL 1 mL single use' with NDC 0703-1501-02 and lot number 31323147B. The product was sold between 2018 and 2019.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the product label, NDC number, and lot number to confirm if it's recalled.
Questions people ask
Is this product safe to use?
The recall indicates impurities were found during stability testing, so it is not safe to use as recalled.
What should I do if I have this product?
The recall does not specify a remedy, so contact your healthcare provider for guidance.
How can I tell if I have the recalled product?
Look for vials with NDC 0703-1501-02 and lot number 31323147B, which were sold between 2018 and 2019.
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0244-2019 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0244-2019 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0244-2019 (September 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0244-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.