Vials Recalled for Glass Delamination Concerns

American Regent Inc is recalling 10 lots of Venofer (iron sucrose) injection because of the potential for glass delamination of the vials, according to the December 11, 2024, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects the following products, which were distributed throughout the United States:

• Venofer injection, 100 mg elemental iron per 5 mL (20 mg/mL), 5-mL single-dose vials (vial NDC 49230-534-01, 25-vial carton NDC 49230-534-25), from lot 4196 (Exp. 5/31/26), distributed by Fresenius Medical Care NA, Waltham, Massachusetts;
• Venofer injection, 50 mg elemental iron per 2.5 mL (20 mg/mL), 2.5-mL single-dose vials (vial NDC 49230-530-01, 10-vial carton NDC 49230-530-10, 25-vial carton NDC 49230-530-25), from lots 4206 and 4210 (Exp. 5/31/26), 4223 (Exp. 6/30/26), and 24231 and 24237 (Exp. 7/31/26), distributed by Fresenius Medical Care NA, Waltham, Massachusetts; and
• Venofer injection, 100 mg elemental iron per 5 mL (20 mg/mL), 5-mL single-dose vials (vial NDC 0517-2340-01, 10-vial carton NDC 0517-2340-10, 25-vial carton NDC 0517-2340-25), from lots 4205 (Exp. 5/31/26), and 24229, 24233, and 24239 (Exp. 7/31/26); distributed by American Regent Inc, Shirley, New York.

American Regent initiated the recalls on November 11, 2024. On November 29, 2024, the FDA designated them Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Venofer is a prescription drug indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.