Hylenex recombinant hyaluronidase injection vials recalled due to temperature excursions during manufacturing. Affected vials have specific NDC and serial numbers. Consumers should contact the manufacturer for details.
cGMP Deviations: Temperature excursion
Hylenex recombinant hyaluronidase injection vials (150 USP units/mL) are being recalled because of temperature excursions during manufacturing. This could potentially affect product safety, though the exact risk is not specified in the recall notice.
Temperature excursions during manufacturing could lead to product instability. This might affect the safety and effectiveness of the injection, but the recall does not specify the exact risk level.
Prescription users of Hylenex injection vials with specific NDC and serial numbers. Healthcare providers and patients who received these vials are most at risk.
Check for NDC 18657-117-04 and serial numbers 100000831961, 100000820688, 100000820689, or 100000820515 on the vial packaging.
Look for NDC 18657-117-04 and specific serial numbers on the vial packaging.
The recall is due to temperature excursions during manufacturing, which could affect product safety.
The recall notice does not specify a remedy, so contact the manufacturer for details.
Check for NDC 18657-117-04 and serial numbers 100000831961, 100000820688, 100000820689, or 100000820515 on the vial packaging.
We’ve drafted a message you can send Halozyme to request your refund or repair — edit it as you like.
Subject: Recall D-0116-2025 — Halozyme Halozyme Hello, I own a Halozyme that is covered by recall D-0116-2025 from Halozyme. 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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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.
