Vitamin B-Complex, 799 mcg/5mL recall — Safecor Health, LLC (Class II)

Safecor Health, LLC is recorded by the U.S. Food and Drug Administration (FDA) as recalling Vitamin B-Complex, 799 mcg/5mL — a Class II recall, initiated 2026-05-01 and posted to the FDA enforcement report on 2026-05-27, under recall number D-0549-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Presence of a Foreign Substance; black particles observed in liquid”. From the product description, the strengths given are 799 mcg/5mL and 5 mL. 1 National Drug Code number is printed in the record: 54859-0516-08. Distribution is recorded as “OH” — Limited / regional distribution, with the recalling firm on record in OH, United States. It is the only recall number the FDA has filed under event ID 98899. Safecor Health, LLC accounts for 2 recall records in the indexed dataset. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0549-2026
FDA event ID 98899
Classification Class II (intermediate regulatory tier)
Status Ongoing
Recalling firm Safecor Health, LLC
Recall initiated 2026-05-01
Reported by FDA 2026-05-27
Report lag 26 days from initiation to report
Distribution OH — Limited / regional distribution
Firm location on record OH, United States
Product description (source) 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

Reason reported by FDA

Presence of a Foreign Substance; black particles observed in liquid

10 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

3 identifying values matched by exact pattern in the 33-word product description above; each is a literal substring of it.

Product named Vitamin B-Complex
Strength 799 mcg/5mL · 5 mL
NDC 54859-0516-08

Other indexed recalls from Safecor Health, LLC

2 indexed records name Safecor Health, LLC as the recalling firm, across 2 FDA events, reported 2026-05-27. A coverage-limited activity count over the ingested window, not a quality rating.

Recall recordRecall numberFDA tierStrength / formReported
Atomoxetine Capsules HCL, 10 mgD-0538-2026Class II10 mg · Capsules2026-05-27

Reported in the same month (2026-05)

48 enforcement reports carry a report date in 2026-05; these 8 are the Class II ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
Liraglutide Injection, 18 mg/3 mLD-0541-2026Lupin Pharmaceuticals Inc.Class II2026-05-27
Gas-X, 125 mgD-0542-2026Haleon US Holdings LLCClass II2026-05-27
Estradiol Gel, 0.1%D-0543-2026Ani Pharmaceuticals, Inc.Class II2026-05-27
Erythromycin Tablets, 250 mgD-0544-2026Zydus Pharmaceuticals (usa) IncClass II2026-05-27
Erythromycin Tablets, 500 mgD-0545-2026Zydus Pharmaceuticals (usa) IncClass II2026-05-27
cimzia (certolizumab pegol)D-0546-2026Ucb Biosciences Inc.Class II2026-05-27
fentaNYL Citrate, 2,2500 mcg/50mLD-0548-2026Integradose Compounding Services LLCClass II2026-05-27
Oasis Tears PF, 10mLD-0525-2026Oasis Medical, Inc.Class II2026-05-20

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 7 nearest to 2026-05-27 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Buprenorphine Hydrochloride, 0.3mg/mLD-0527-2026Endo Usa, Inc.0.3mg/mL · Injection2026-05-20
Ascend Laboratories, 25 mgD-0547-2026Ascend Laboratories, LLC25 mg · Extended-Release Tablets2026-05-20
DELFLEX, 1.5%D-0512-2026Fresenius Medical Care Holdings, Inc.1.5% · Solution2026-05-13
DELFLEX, 2.5%D-0513-2026Fresenius Medical Care Holdings, Inc.2.5% · Solution2026-05-13
Duloxetine Delayed-Release Capsules, 30 mgD-0514-2026Ajanta Pharma Ltd.30 mg · Delayed-Release Capsules2026-05-13
Duloxetine Delayed-Release Capsules, 60 mgD-0515-2026Ajanta Pharma Ltd.60 mg · Delayed-Release Capsules2026-05-13
Duloxetine Delayed-Release Capsules, 20 mgD-0516-2026Ajanta Pharma Ltd.20 mg · Delayed-Release Capsules2026-05-13

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. Match a package against 54859-0516-08 at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Safecor Health, LLC (2 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0549-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0549-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-05-27
Ingested
2026-08-22
Record hash
4c5db447bb2a3d9a

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.