Staska Pharmaceuticals, Inc.
FDA 503B outsourcing facility
Bennet, Nebraska
Key Takeaways
- FDA-registered 503B outsourcing facility since 2020
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: February 20, 2026
- 1 FDA drug recall on record (2024)
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
- December 3, 2020
- Most recent registration
- December 12, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- February 20, 2026
The FDA last inspected Staska Pharmaceuticals, Inc. on February 20, 2026. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
Staska Pharmaceuticals, Inc. has 1 FDA drug recall on record in 2024, based on the FDA enforcement database. Breakdown: 1 Class I.
Recall reasons on record include presence of particulate matter: presence of glass particulates.
| Date | Class | Product | Reason |
|---|---|---|---|
| September 2024 | Class I | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, N | Presence of Particulate Matter: Presence of glass particulates. |
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
Staska Pharmaceuticals, Inc. reports compounding 9 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Glutathione.
- Ascorbic Acid
- Epinephrine; Lidocaine
- Glutathione
- Isosulfan Blue
- Lidocaine
- Methylcobalamin
- Riboflavin 5'-Phosphate Sodium; Thiamine Hydrochloride; Niacinamide; Dexpanthenol; Pyridoxine Hydrochloride
- Thiamine Hydrochloride; Niacinamide
- Zinc Sulfate
Location
742 Evergreen Dr, N/A, Bennet, NE 68317-2365
Contact
FDA-registered contact: Lyndon Leitner, 402-782-2207. 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 Staska Pharmaceuticals, Inc. with the Nebraska Board of Pharmacy.
503B facilities in Nebraska
Frequently asked questions
Is Staska Pharmaceuticals, Inc. registered with the FDA?
Yes. Staska Pharmaceuticals, Inc. is a registered 503B outsourcing facility, first registered with the FDA on December 3, 2020 and most recently registered on December 12, 2025.
Has Staska Pharmaceuticals, Inc. been inspected by the FDA?
The FDA last inspected Staska Pharmaceuticals, Inc. on February 20, 2026. A Form FDA 483 was issued.
Has Staska Pharmaceuticals, Inc. had any FDA drug recalls?
Staska Pharmaceuticals, Inc. has 1 FDA drug recall on record (2024) in the FDA enforcement database.
What does Staska Pharmaceuticals, Inc. compound?
Staska Pharmaceuticals, Inc. reports compounding 9 active ingredients to the FDA, including Glutathione.
Where is Staska Pharmaceuticals, Inc. located?
Staska Pharmaceuticals, Inc. is located in Bennet, Nebraska (742 Evergreen Dr).
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 Staska Pharmaceuticals, Inc.. 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.