Fagron Compounding Services
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0440-2026 | Class II | Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Servi | March 20, 2026 |
| D-0441-2026 | Class II | Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Servic | March 20, 2026 |
| D-0439-2026 | Class II | norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Service | March 20, 2026 |
| D-0442-2026 | Class II | Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, | March 20, 2026 |
| D-0438-2026 | Class II | norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services | March 20, 2026 |
| D-0221-2026 | Class II | Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5m | November 20, 2025 |
| D-0646-2025 | Class II | bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron S | August 29, 2025 |
| D-0225-2025 | Class II | fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fag | January 31, 2025 |
| D-0636-2024 | Class II | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Ser | August 15, 2024 |
| D-0125-2024 | Class III | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% | November 10, 2023 |