Where's it on?
FDA · Drugs ·

Tyenne (tocilizumab-aazg) Injection recall

Fresenius Kabi USA, LLC recalled Tyenne (tocilizumab-aazg) Injection on September 2, 2026 because of presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. It was sold nationwide.

Why it was recalled

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

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.

Quantity: 4,643 20mL-vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Fresenius Kabi USA, LLC, Lake Zurich, IL
Date
Severity
Class I · most serious
the most serious: the product could cause serious health problems or death.
Where sold
Nationwide
Nationwide in the USA
Status
Ongoing
Recall number
D-0827-2026
Source
U.S. Food and Drug Administration

More drugs recalls

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCClear Eyes Redness Relief
· Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCLubricant Eye Drops-Cameron Pharmaceuticals
· Sterling Pharmaceutical Services LLCReliable -1 Laboratories
· Sterling Pharmaceutical Services LLC