May 2026 FDA Recall Drug by Safecor Health, Llc
D-0549-2026 - Presence of a Foreign Substance; black particles observed in liquid
This Class II drug recall was voluntarily initiated by Safecor Health, Llc on May 1, 2026 for the product Drug. The FDA reported the reason for recall as presence of a foreign substance; black particles observed in liquid. The product was distributed in OH and the recall is currently ongoing.
Recall Number: D-0549-2026
Presence of a Foreign Substance; black particles observed in liquid
05-01-2026
05-27-2026
520 syringes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Safecor Health, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
Batch or Lot Expiration Information
Lot# Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026
