Fresenius Kabi Phenylephrine Injection Recall: Cgmp Violations

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Recalling firmFresenius Kabi Compounding, LLC20 Dan Rd, N/A · Canton, MA 02021-2809

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Kabi is recalling phenylephrine injections that were made under cGMP violations. This means the product may not be safe for medical use, and affected patients should contact the manufacturer for guidance.

Why it’s dangerous

The product was made under cGMP violations, which are quality control standards for pharmaceuticals. This could mean the injection is not safe for medical use, but the exact risk is not specified in the recall.

Who’s affected

Patients prescribed phenylephrine injections by a healthcare provider. Those with the specific lot numbers and expiration dates listed in the recall are most at risk.

How to tell if you have this one

Check the product label for the lot number C274-000037039 (expiring 9 October 2024) or C274-000037239 (expiring 21 October 2024). The product is a single-dose injection for prescription use.

Brand
Fresenius Kabi
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot numbers C274-000037039 (expiring 9 October 2024) or C274-000037239 (expiring 21 October 2024) on the injection bottle.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states there were cGMP violations, which could mean the product is not safe for medical use, but the exact risk is not specified.

How do I know if I have the recalled product?

Check the product label for the lot numbers C274-000037039 (expiring 9 October 2024) or C274-000037239 (expiring 21 October 2024).

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact Fresenius Kabi directly for guidance.

Take action

Contact Fresenius Kabi

We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0016-2025 — Fresenius Kabi Fresenius Kabi

Hello,

I own a Fresenius Kabi that is covered by recall D-0016-2025 from Fresenius Kabi.

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-0016-2025 (September 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0016-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.

Fresenius Kabi Compounding, LLC recalls Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile

Recall notice