Fagron Compounding Services dba Fagron Sterile Services
FDA 503B outsourcing facility
Wichita, Kansas
Key Takeaways
- FDA-registered 503B outsourcing facility since 2015
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: August 8, 2025
- FDA action: Regulatory Meeting Held 2/27/2026
- 13 FDA drug recalls on record (2017 to 2026)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- October 2, 2015
- Most recent registration
- November 21, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- August 8, 2025
The FDA last inspected Fagron Compounding Services dba Fagron Sterile Services on August 8, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Regulatory Meeting Held 2/27/2026.
FDA recall history
Fagron Compounding Services dba Fagron Sterile Services has 13 FDA drug recalls on record between 2017 and 2026, based on the FDA enforcement database. Breakdown: 2 Class I, 10 Class II, 1 Class III.
Recall reasons on record include lack of assurance of sterility; blue break-off-part could detach from the administration; incorrect product formulation; lack of assurance of sterility; labeling: label mix-up: the label of a dropper bottle mistakenly states the container is; labeling: label error on declared strength: syringes of neostigmine methylsulfate 1 mg.
| Date | Class | Product | Reason |
|---|---|---|---|
| March 2026 | Class II | 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, | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port |
| March 2026 | Class II | 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, | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port |
| March 2026 | Class II | norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, N | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port |
| March 2026 | Class II | norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, ND | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port |
| March 2026 | Class II | Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port |
Showing the 5 most recent of 13 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
Fagron Compounding Services dba Fagron Sterile Services reports compounding 42 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Oxytocin, Semaglutide.
- Atropine Sulfate
- Betamethasone Sodium Phosphate
- Bevacizumab
- Bupivacaine Hydrochloride
- Dexamethasone Sodium Phosphate
- Dextrose Monohydrate
- Ephedrine Sulfate
- Epinephrine
- Fentanyl Citrate
- Fentanyl Citrate; Bupivacaine Hydrochloride
- Fentanyl Citrate; Ropivacaine Hydrochloride
- Glycopyrrolate
- Hydromorphone Hydrochloride
- Iohexol
- Ketamine Hydrochloride
- Lidocaine Hydrochloride
- Lidocaine Hydrochloride; Epinephrine Bitartrate; Tetracaine Hydrochloride
- Lysine Hydrochloride; Arginine Hydrochloride
- Methylprednisolone Acetate
- Midazolam
- Mitomycin
- Moxifloxacin Hydrochloride
- Neostigmine Methylsulfate
- Norepinephrine Bitartrate
- Oxytocin
- Phenol
- Phenylephrine Hydrochloride
- Phenylephrine Hydrochloride; Cyclopentolate Hydrochloride; Tropicamide
- Phenylephrine Hydrochloride; Ketorolac Tromethamine; Tropicamide; Cyclopentolate Hydrochloride
- Phenylephrine Hydrochloride; Ketorolac Tromethamine; Tropicamide; Cyclopentolate Hydrochloride; Proparacaine Hydrochloride
and 12 more.
Location
8710 E 34th St N, Wichita, KS 67226-2636
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Contact
FDA-registered contact: Deborah McHugh, 316-773-0405. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Fagron Compounding Services dba Fagron Sterile Services with the Kansas Board of Pharmacy.
503B facilities in Kansas
Frequently asked questions
Is Fagron Compounding Services dba Fagron Sterile Services registered with the FDA?
Yes. Fagron Compounding Services dba Fagron Sterile Services is a registered 503B outsourcing facility, first registered with the FDA on October 2, 2015 and most recently registered on November 21, 2025.
Has Fagron Compounding Services dba Fagron Sterile Services been inspected by the FDA?
The FDA last inspected Fagron Compounding Services dba Fagron Sterile Services on August 8, 2025. A Form FDA 483 was issued. FDA action on record: Regulatory Meeting Held 2/27/2026.
Has Fagron Compounding Services dba Fagron Sterile Services had any FDA drug recalls?
Fagron Compounding Services dba Fagron Sterile Services has 13 FDA drug recalls on record (2017 to 2026) in the FDA enforcement database.
What does Fagron Compounding Services dba Fagron Sterile Services compound?
Fagron Compounding Services dba Fagron Sterile Services reports compounding 42 active ingredients to the FDA, including Oxytocin, Semaglutide.
Where is Fagron Compounding Services dba Fagron Sterile Services located?
Fagron Compounding Services dba Fagron Sterile Services is located in Wichita, Kansas (8710 E 34th St N).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Fagron Compounding Services dba Fagron Sterile Services. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.