Recall of CUROSURF Drug by Chiesi USA Due to Sterility Concerns
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
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 ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,184 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.