US Specialty Formulations LLC
FDA 503B outsourcing facility
Allentown, Pennsylvania
Key Takeaways
- FDA-registered 503B outsourcing facility since 2014
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: January 14, 2026
- 2 FDA drug recalls on record (2022)
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
- January 31, 2014
- Most recent registration
- December 3, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- January 14, 2026
The FDA last inspected US Specialty Formulations LLC on January 14, 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
US Specialty Formulations LLC has 2 FDA drug recalls on record in 2022, based on the FDA enforcement database. Breakdown: 2 Class II.
Recall reasons on record include lack of assurance of sterility.
| Date | Class | Product | Reason |
|---|---|---|---|
| May 2022 | Class II | B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Rib | Lack of Assurance of Sterility |
| May 2022 | Class II | Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69 | Lack of Assurance of Sterility |
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
US Specialty Formulations LLC reports compounding 1 distinct active ingredient to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Sarracenia Purpurea
Location
1401 S Albert St, Allentown, PA 18103-4141
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Contact
FDA-registered contact: Kyle Flanigan, 610-849-5023. 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 US Specialty Formulations LLC with the Pennsylvania State Board of Pharmacy.
503B facilities in Pennsylvania
Pennsylvania has 5 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Pennsylvania.
Frequently asked questions
Is US Specialty Formulations LLC registered with the FDA?
Yes. US Specialty Formulations LLC is a registered 503B outsourcing facility, first registered with the FDA on January 31, 2014 and most recently registered on December 3, 2025.
Has US Specialty Formulations LLC been inspected by the FDA?
The FDA last inspected US Specialty Formulations LLC on January 14, 2026. A Form FDA 483 was issued.
Has US Specialty Formulations LLC had any FDA drug recalls?
US Specialty Formulations LLC has 2 FDA drug recalls on record (2022) in the FDA enforcement database.
What does US Specialty Formulations LLC compound?
US Specialty Formulations LLC reports compounding 1 active ingredient to the FDA.
Where is US Specialty Formulations LLC located?
US Specialty Formulations LLC is located in Allentown, Pennsylvania (1401 S Albert St).
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 US Specialty Formulations LLC. 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.