Recall of CUROSURF Drug by Chiesi USA Due to Sterility Concerns

Source: FDA · United States

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Chiesi USA, Inc. is voluntarily recalling 7,235 vials of CUROSURF (poractant alfa) due to a lack of assurance of sterility, affecting nationwide distribution in the United States.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall of CUROSURF Drug

What Happened

Chiesi USA, Inc. is initiating a voluntary recall of CUROSURF because of a lack of assurance of sterility.

Which Products Are Affected

The affected product is CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, in 3 mL single-dose vials. The NDC number is 10122-510-03, with package NDCs 10122-510-01 and 10122-510-03. A total of 7,235 vials are involved, from lots 1213748 (expiration date September 2026), 1215076, and 1215077 (expiration date October 2026). This recall affects nationwide distribution within the United States.

What You Should Do

Consumers should stop using the affected lots of CUROSURF and contact Chiesi USA, Inc. for instructions, as the initial notification was via letter. The firm is located at 175 Regency Woods Pl Ste 600, Cary, NC 27518-6007.

Why This Matters

This recall addresses potential risks associated with a prescription drug, highlighting the need for sterility in medical products to protect patient health.

Source

This information is attributed to the U.S. Food and Drug Administration (FDA). For more details, visit the FDA website and search for recall number D-0402-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Chiesi USA, Inc. is voluntarily recalling 7,235 vials of CUROSURF (poractant alfa) due to a lack of assurance of sterility, affecting nationwide distribution in the United States.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.