Sagent Pharmaceuticals Inc recalls Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per
Sagent Pharmaceuticals recalls phenylephrine injection vials with loose crimped seals that may cause non-sterile product. Affected lots from India, expiring 08/2022 and 09/2022. Stop using immediately if you have these vials.
Use caution until it’s fixed
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Contact the company & request your remedy
What happened, in plain English
Sagent Pharmaceuticals is recalling phenylephrine injection vials that may have loose seals, risking non-sterile product. This could lead to infections if used improperly. The recall affects vials manufactured in India with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/36482-sagent-pharmaceuticals-phenylephrine-injection-recall-loose-vial-seals-risk-non.
Source Summary by GovInfoNow · govinfonow.com/recall/36482-sagent-pharmaceuticals-phenylephrine-injection-recall-loose-vial-seals-risk-non · Updated October 4, 2026 · FDA enforcement record: FDA #D-0305-2021
Cite this page
“Sagent Pharmaceuticals Phenylephrine Injection Recall: Loose Vial Seals Risk Non-Sterile Product.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36482-sagent-pharmaceuticals-phenylephrine-injection-recall-loose-vial-seals-risk-non. 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
Loose crimped vial seals can allow contamination, potentially leading to non-sterile product. This poses a risk of infection if the injection is administered without proper sterility.
Who’s affected
Healthcare professionals who use these injections for intravenous treatment are most at risk. Patients receiving these injections under medical supervision may also be affected.
How to tell if you have this one
Check for vials with loose crimped seals. The product is packaged in 25 x 1 mL single-dose vials per carton, made in India, with lot numbers PHT8IB2, PHT9IB2 (expiring 08/2022) or PHT1JB2 (expiring 09/2022).
- Brand
Sagent Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Seals
Inspect for loose crimped vial seals that may indicate a non-sterile product.
Questions people ask
What is the product name?
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton.
What lot numbers are affected?
Lots PHT8IB2, PHT9IB2 (expiring 08/2022) and PHT1JB2 (expiring 09/2022).
How can I tell if I have the recalled product?
Look for vials with loose crimped seals; the product was made in India with specific lot numbers and expiration dates.
Contact Sagent Pharmaceuticals
We’ve drafted a message you can send Sagent Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0305-2021 — Sagent Pharmaceuticals Sagent Pharmaceuticals Hello, I own a Sagent Pharmaceuticals that is covered by recall D-0305-2021 from Sagent 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-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 qwen3:4b on October 4, 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.