Hylenex injection recall: Temperature issues may cause safety risks
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.
Recall notice
cGMP Deviations: Temperature excursion
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/32545-hylenex-injection-recall-temperature-issues-may-cause-safety-risks.
Source Summary by GovInfoNow · govinfonow.com/recall/32545-hylenex-injection-recall-temperature-issues-may-cause-safety-risks · Updated August 17, 2026 · FDA enforcement record: FDA #D-0116-2025
Cite this page
“Hylenex injection recall: Temperature issues may cause safety risks.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32545-hylenex-injection-recall-temperature-issues-may-cause-safety-risks. Based on FDA recall #D-0116-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0116-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Prescription users of Hylenex injection vials with specific NDC and serial numbers. Healthcare providers and patients who received these vials are most at risk.
How to tell if you have this one
Check for NDC 18657-117-04 and serial numbers 100000831961, 100000820688, 100000820689, or 100000820515 on the vial packaging.
- Brand
Halozyme- Category
Drug
What to do — step by step
Check Vial Details
Look for NDC 18657-117-04 and specific serial numbers on the vial packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0116-2025 (September 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0116-2025 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.