Lower risk Drug recall · FDA · Published August 4, 2026

Fresen: Morphine Syringes May Have Wrong Labeling - Risk of Incorrect Medication

Fresenius Kabi recalls Morphine Sulfate Injection syringes that may be labeled incorrectly with Dilaudid instead of Morphine. This could lead to incorrect medication use. Consumers should check labels and contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0788-2026Drug Fresenius Kabi ›

Fresenius Kabi — official photo 1 — Official FDA recall photos · click to enlarge

Lower-risk recall

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

✎ GovInfoNow plain-language explainer

Fresenius Kabi is recalling Morphine Sulfate Injection syringes that may have been labeled incorrectly as containing Dilaudid instead of Morphine. This could cause someone to receive the wrong medication if used. Read more at govinfonow.com/recall/692866-fresen-morphine-syringes-may-have-wrong-labeling-risk-of-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/692866-fresen-morphine-syringes-may-have-wrong-labeling-risk-of-incorrect · Updated September 14, 2026 · FDA enforcement record: FDA #D-0788-2026

Cite this page

“Fresen: Morphine Syringes May Have Wrong Labeling - Risk of Incorrect Medication.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692866-fresen-morphine-syringes-may-have-wrong-labeling-risk-of-incorrect. Based on FDA recall #D-0788-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0788-2026%22&limit=1).

The FDA announced on 2026-08-04 that Fresenius Kabi USA, LLC is recalling Morphine Sulfate Injection prefilled syringes due to a labeling mix-up. The hazard involves MicroVault-labeled syringes actually containing Dilaudid instead of the labeled Morphine.

How to tell if you have it

Brand: Fresenius Kabi
Product: Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes
NDC Unit of Use: 76045-004-01
NDC Unit of Sale: 76045-004-11
Lot #: 6402820
Exp. Date: 12/2028

The hazard

The recall addresses a labeling mix-up where MicroVault-labeled syringes contain Dilaudid 0.5 mg/0.5 mL instead of the labeled Morphine Sulfate 2 mg/1 mL.

Context

GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since 2012-09-27. Recent similar recalls include a Tyenne Injection recall for glass particles (2026-08-10), a Glycopyrrolate Injection recall for hair found in the product (2026-07-16), and an Epinephrine Injection recall for failed impurities (2026-05-14). Other recent recalls of similar products include a Winder Morphine Sulfate Oral Solution recall for mispack size mismatch (2025-11-26), an American Health Packaging Buprenorphine Tablets recall for label mix-up hazard (2026-08-19), and an American Regent Levocarnitine Injection recall for missing label hazard (2026-04-16).

How to tell if you have this one

Check for the NDC numbers 76045-004-01 or 76045-004-11 on the syringe packaging. The syringes were sold with Lot #6402820 and expire December 2028.

Brand
Fresenius Kabi
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Label
Look for the label indicating it contains Dilaudid 0.5 mg/0.5 mL instead of Morphine 2 mg/1 mL.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 22 days after the firm started it.

Aug 4, 2026Firm started the recall
Aug 24, 2026FDA classified it Class I
Aug 26, 2026Published in FDA’s Enforcement Report
Sep 8, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Fresenius Kabi recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/692866-fresen-morphine-syringes-may-have-wrong-labeling-risk-of-incorrect">Fresen: Morphine Syringes May Have Wrong Labeling - Risk of Incorrect Medication (GovInfoNow)</a>

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-0788-2026 (August 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0788-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.