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Safecor Health, LLC FDA Recalls
20 recalls on file across drugs, 0 of them Class I and 19 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use OnlClass IIAug 13, 2026Failed Stability Specifications |
| Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use OnlClass IIAug 13, 2026Failed Stability Specifications |
| Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use OnlyClass IIAug 13, 2026Failed Stability Specifications |
| Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use OnlClass IIAug 13, 2026Failed Stability Specifications |
| Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use OnlClass IIAug 13, 2026Failed Stability Specifications |
| Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use OnlClass IIAug 13, 2026Failed Stability Specifications |
| Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mClass IIMay 1, 2026Presence of a Foreign Substance; black particles observed in |
| Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Class IIApr 30, 2026Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorre |
| Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, ManuClass IIOct 10, 2025Labeling: Not Elsewhere Classified:Incorrect RFID tag labels |
| Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: SafecoClass IIFeb 17, 2025Defective Delivery System: Leakage observed after oral solut |
| Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, ColClass IIFeb 17, 2025Defective Delivery System: Leakage observed after oral solut |
| Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Class IIFeb 17, 2025Defective Delivery System: Leakage observed after oral solut |
| Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg bClass IIFeb 17, 2025Defective Delivery System: Leakage observed after oral solut |
| Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, MfClass IIFeb 17, 2025Defective Delivery System: Leakage observed after oral solut |
| Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01Class IINov 11, 2024cGMP Deviations: Observations were made that some blister ca |
| Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 4Class IINov 11, 2024cGMP Deviations: Observations were made that some blister ca |
| Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-0Class IINov 11, 2024cGMP Deviations: Observations were made that some blister ca |
| Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433Class IINov 11, 2024cGMP Deviations: Observations were made that some blister ca |
| Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01Class IINov 11, 2024cGMP Deviations: Observations were made that some blister ca |
| Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor HealthClass IIOct 19, 2023CGMP Deviations: Recall due to the absence of USP CGMP compe |