Safecor Health, LLC

FDA Regulatory Profile

Safecor Health, LLC appears in FDA public data with 30 recalls, 0 510(k) clearances, 16 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0846-2026, Class II) was initiated on August 13, 2026.

Summary

Total Recalls
30
510(k) Clearances
0
Inspections
16
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0846-2026Class IIFluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by voluAugust 13, 2026
D-0845-2026Class IIFluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by voluAugust 13, 2026
D-0844-2026Class IIFluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by voluAugust 13, 2026
D-0841-2026Class IIFluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by voluAugust 13, 2026
D-0843-2026Class IIFluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by voluAugust 13, 2026
D-0842-2026Class IIFluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volumAugust 13, 2026
D-0549-2026Class IIVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mMay 1, 2026
D-0538-2026Class IIAtomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 10April 30, 2026
D-0214-2026Class IIHaloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For IntramuscOctober 10, 2025
D-0251-2025Class IISimethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: SafeFebruary 17, 2025
D-0253-2025Class IILorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, RefrigerateFebruary 17, 2025
D-0254-2025Class IIMorphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: HFebruary 17, 2025
D-0252-2025Class IIFerrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: AkFebruary 17, 2025
D-0250-2025Class IIErgocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 February 17, 2025
D-0060-2025Class IIDocusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.November 11, 2024
D-0056-2025Class IIVitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, November 11, 2024
D-0057-2025Class IIVitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com,November 11, 2024
D-0058-2025Class IIAspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhNovember 11, 2024
D-0059-2025Class IICalcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safeNovember 11, 2024
D-0082-2024Class IIStrong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX October 19, 2023