D-0795-2026 Class II Ongoing
FDA drug recall D-0795-2026 was initiated by American Regent, Inc. on July 24, 2026 and is designated Class II. Reason for recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde The recall status is ongoing. Affected quantity: 89,775 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- July 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,775 vials
Product Description
Atropine 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), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.
Reason for Recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: 24353, Exp. Date: 9/30/2026.