Fagron Compounding Services recalls
Fagron Compounding Services appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-04-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2017-07-12 to 2026-04-15 |
| By agency | FDA Drug (13) |
| By classification | Class II (10), Class I (2), Class III (1) |
| By status | ongoing (9), terminated (3), completed (1) |
| Distribution named in notices | PA, US |
Recalls
- norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226,…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, ND…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, N…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226,…
FDA Drug · Class II · 2026-04-15 · Fagron Compounding Services
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port - Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophth…
FDA Drug · Class II · 2025-12-17 · Fagron Compounding Services
Reason: Incorrect Product Formulation - bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wich…
FDA Drug · Class II · 2025-09-24 · Fagron Compounding Services
Reason: Lack of Assurance of Sterility - fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N,…
FDA Drug · Class II · 2025-02-26 · Fagron Compounding Services
Reason: Lack 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 St, N. Wichita, KS…
FDA Drug · Class II · 2024-08-28 · Fagron Compounding Services
Reason: Lack of Assurance of Sterility - Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Oph…
FDA Drug · Class III · 2023-12-06 · Fagron Compounding Services
Reason: Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper - Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron S…
FDA Drug · Class I · 2018-07-11 · Fagron Compounding Services
Reason: Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL. - Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron S…
FDA Drug · Class I · 2018-07-11 · Fagron Compounding Services
Reason: Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL. - Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe
FDA Drug · Class II · 2017-07-12 · Fagron Compounding Services
Reason: Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier