Class I U.S. Food and Drug Administration

Fresenius Kabi USA, LLC Tyenne Injection, 400 mg/20 mL , 20 mL vial recall: Presence of particulate matter:An internal investigation at the firm found

Recall published last month

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

The hazard

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Recall details

Recall number
D-0827-2026
Published
September 2, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Kabi USA, LLC
Product type
Prescription & OTC drugs
Units affected
4,643 20mL-vials
Distribution
Nationwide
Made in
United States
Lot / code info
Lot: 16UI07, Exp 08/31/2028

Products covered by this recall

Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.

What to do if you are taking this medicine

Do not stop a prescription on your own. A recalled drug is usually still safer than an untreated condition, and your pharmacist can swap the lot the same day.

  1. Compare the lot number and expiry date on your bottle or carton with the codes listed above. Only those lots are recalled.
  2. Keep taking the medicine until you have spoken to your prescriber or pharmacist, unless the notice above says to stop immediately. Abruptly stopping some drugs is more dangerous than the defect itself.
  3. Call the pharmacy that dispensed it. They can see which lot they gave you and will normally replace it from unaffected stock at no charge.
  4. Report any side effect you think the product caused to the FDA MedWatch programme at fda.gov/medwatch — that reporting is what triggers most drug recalls in the first place.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs you nothing.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price; keep the receipt the pharmacy issues for the return.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue — recall claims are handled separately.
  • If the recall voided a prescription you had already paid for in full, your insurer will normally re-authorise a replacement fill ahead of schedule. Mention the recall number when you call.

Company contact: Fresenius Kabi USA, LLC — 3 Corporate Dr, Lake Zurich, IL, 60047-8930

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

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