Recall RadarAtropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25)…
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. 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
- American Regent, Inc. — Shirley, NY
- Severity
- Class II — moderate
- Reported
- August 26, 2026
- Quantity
- 89,775 vials
- Recall number
- D-0795-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide within the U.S
Other medicine & devices recalls
-
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.
Class I — serious · FDA · September 2, 2026 · Fresenius Kabi USA, LLC
-
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.