Sagent Recalls Phenylephrine HCl Injection Due to Sterility Risk
Sagent Pharmaceuticals recalls specific lots of Phenylephrine HCl Injection due to lack of sterility assurance from loose crimped vial overseals.
Stop using this now
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Contact the company
What happened, in plain English
Sagent Pharmaceuticals Inc has recalled Phenylephrine HCl Injection, USP, 10 mg per mL, packaged in single-dose vials. The recall addresses customer complaints regarding loose crimped vial overseals, which may result in the product being non-sterile. This affects specific lots distributed nationwide in the USA and Puerto Rico. Read more at govinfonow.com/recall/36482-sagent-recalls-phenylephrine-hcl-injection-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36482-sagent-recalls-phenylephrine-hcl-injection-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0305-2021
Cite this page
“Sagent Recalls Phenylephrine HCl Injection Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36482-sagent-recalls-phenylephrine-hcl-injection-due-to-sterility-risk. Based on FDA recall #D-0305-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0305-2021%22&limit=1).
Why it’s dangerous
The vial overseals may be loose due to crimping issues, which compromises the seal. This lack of assurance of sterility means the injection could contain harmful contaminants, posing a serious health risk if administered intravenously.
Who’s affected
Patients or healthcare providers who purchased Phenylephrine HCl Injection from Sagent Pharmaceuticals between the manufacturing dates and expiration dates listed below, specifically those in the USA and Puerto Rico. Individuals using these specific lots are at risk of exposure to non-sterile medication.
How to tell if you have this one
Check for Phenylephrine HCl Injection, USP, 10 mg per mL, in single-dose vials packaged in cartons of 25. Look for NDC 25021-315-01 and the following lots with their expiration dates: PHT8IB2 (exp 08/2022), PHT9IB2 (exp 08/2022), and PHT1JB2 (exp 09/2022). The product is marked 'For Intravenous Use, Rx only' and manufactured for Sagent Pharmaceuticals in Schaumburg, IL.
- Brand
Sagent Pharmaceuticals- Category
Drug
What to do — step by step
Stop using the product
Do not use any Phenylephrine HCl Injection from the recalled lots due to sterility concerns.
Contact your provider
Consult with a healthcare professional or pharmacist regarding alternative treatments if you have used or possess the affected product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the affected product is 25021-315-01.
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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-0305-2021 (March 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0305-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.