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Fagron Compounding Services FDA Recalls
10 recalls on file across drugs, 0 of them Class I and 9 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 |
|---|
| Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. NClass IIMar 20, 2026Lack of Assurance of Sterility; blue Break-Off-Part could de |
| norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Class IIMar 20, 2026Lack of Assurance of Sterility; blue Break-Off-Part could de |
| Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N.Class IIMar 20, 2026Lack of Assurance of Sterility; blue Break-Off-Part could de |
| Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. WiClass IIMar 20, 2026Lack of Assurance of Sterility; blue Break-Off-Part could de |
| norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. WClass IIMar 20, 2026Lack of Assurance of Sterility; blue Break-Off-Part could de |
| Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use SyringeClass IINov 20, 2025Incorrect Product Formulation |
| bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 871Class IIAug 29, 2025Lack of Assurance of Sterility |
| fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile ServicesClass IIJan 31, 2025Lack of Assurance of Sterility |
| Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th Class IIAug 15, 2024Lack of Assurance of Sterility |
| Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottlClass IIINov 10, 2023Labeling: Label Mix-Up: The label of a dropper bottle mistak |