FDA Issues Class II Recall for Ergocalciferol Supplements

A Class II recall has been issued for Ergocalciferol (Vitamin D) Supplement, 10 mcg (400 Units) per 0.05 mL Oral Syringe, manufactured by Westminster and repackaged by Safecor Health, LLC. The recall affects 3069 oral syringes from Lot #24300812 (Exp. 01/31/2025) and Lot #24530836 (Exp. 07/19/2025). The recall was initiated due to a defective delivery system, where leakage was observed in unit-dose syringes, potentially leading to inaccurate dosing and reduced effectiveness of the supplement. The recall began on February 17, 2025, and remains ongoing.

The recalling firm, Safecor Health, LLC, based in Columbus, Ohio, has notified its consignees via letters. The US Food and Drug Administration (FDA) classified the recall as Class II on March 5, 2025, meaning the defect may cause temporary or medically reversible health issues, but serious adverse effects are unlikely. 

Ergocalciferol (Vitamin D2) treats or prevents vitamin D deficiencies, including conditions like rickets, osteoporosis, and hypoparathyroidism. Leakage in the oral syringes may result in underdosing, reducing the supplement's effectiveness and potentially impacting patient outcomes.