Recall RadarTyenne (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.
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. This recall is in the most serious category, meaning the agency believes it can cause serious injury or death — don't finish the package or use up what's left. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Fresenius Kabi USA, LLC — Lake Zurich, IL
- Severity
- Class I — serious
- Reported
- September 2, 2026
- Quantity
- 4,643 20mL-vials
- Recall number
- D-0827-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide in the USA
Other medicine & devices recalls
-
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00
Class I — serious · FDA · September 2, 2026 · B BRAUN MEDICAL INC
-
Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCNEIL, Pkg by: Safecor, Woburn, MA
Class I — serious · FDA · September 2, 2026 · Safecor Health, LLC
-
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Ac…
Class II — moderate · FDA · September 2, 2026 · ACCORD HEALTHCARE, INC.
-
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc…
Class II — moderate · FDA · September 2, 2026 · Hikma Pharmaceuticals USA INC.
-
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceutic…
Class II — moderate · FDA · September 2, 2026 · ACCORD HEALTHCARE, INC.
-
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceut…
Class II — moderate · FDA · September 2, 2026 · ACCORD HEALTHCARE, INC.
-
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuti…
Class II — moderate · FDA · September 2, 2026 · ACCORD HEALTHCARE, INC.
-
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Acco…
Class II — moderate · FDA · September 2, 2026 · ACCORD HEALTHCARE, INC.