Skip to main content
Skip to recall details
Verified · FDAClass I — Health RiskMedications

Tyenne Injection, 400 mg/20 mL , 20 mL vial, Rx Only Recall 2026

TYENNEIssued August 10, 2026Updated Reviewed by the Recall Watch editorial team

TYENNE 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. — recalled per FDA on 8/10/2026. Reason: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles..

Agency
FDA
Issued
Aug 10, 2026
Brand
TYENNE
Distribution
1 states
Lots affected
2
What to do right nowHigh risk

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Free case review

Were you or someone in your household prescribed this medication?

  • Free
  • No obligation
  • Licensed attorneys
Attorney advertising.Details

Recall Watch is not a law firm and does not provide legal or medical advice. Free case reviews are provided by independent licensed attorneys; Recall Watch may receive a referral fee. Prior results do not guarantee a similar outcome. Submitting this form does not create an attorney-client relationship. See our terms and privacy policy.

Verified summary of the official U.S. Food and Drug Administration notice · Issued August 10, 2026 · Last synced Nov 1, 2026

What's recalled

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.

Available at AmazonAd
White first-aid box with bandages

Restock your medicine cabinet

First-aid kits, thermometers and OTC basics, searched on Amazon.

Shop at Amazon.com

Need it delivered? Start a free Amazon Prime trial.

Why it was recalled

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

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot: 16UI07
Exp 08/31/2028
Where was it sold
1 state

Nationwide in the USA

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the TYENNE recall still active?

Yes, this recall is currently active as of August 10, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot: 16UI07, Exp 08/31/2028. Check the label on your product.

What should I do if I have the recalled TYENNE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.