STAQ Pharma, Inc.
FDA 503B outsourcing facility
Denver, Colorado
Key Takeaways
- FDA-registered 503B outsourcing facility since 2019
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: February 10, 2025
- FDA action: FMD-145 Letter Issued 6/6/2025
- 6 FDA drug recalls on record (2022 to 2025)
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
- February 5, 2019
- Most recent registration
- December 18, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- February 10, 2025
The FDA last inspected STAQ Pharma, Inc. on February 10, 2025. No Form FDA 483 was issued at that inspection. FDA action on record: FMD-145 Letter Issued 6/6/2025.
FDA recall history
STAQ Pharma, Inc. has 6 FDA drug recalls on record between 2022 and 2025, based on the FDA enforcement database. Breakdown: 2 Class I, 1 Class II, 3 Class III.
Recall reasons on record include labeling: incorrect or missing lot and/or exp date; staq pharma inc. received consumer complaints related to leaking bags and other potential; labeling: label mix up; a limited number of syringes containing hydromorphone hcl pf were.
| Date | Class | Product | Reason |
|---|---|---|---|
| October 2025 | Class III | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC | Labeling: Incorrect or Missing Lot and/or Exp Date |
| October 2025 | Class III | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colora | Labeling: Incorrect or Missing Lot and/or Exp Date |
| October 2025 | Class III | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Color | Labeling: Incorrect or Missing Lot and/or Exp Date |
| November 2023 | Class II | ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, | STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who rel |
| February 2022 | Class I | HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: | Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A |
Showing the 5 most recent of 6 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
STAQ Pharma, Inc. reports compounding 21 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Albuterol Sulfate
- Atropine Sulfate
- Desmopressin Acetate
- Dexmedetomidine Hydrochloride
- Epinephrine Bitartrate
- Epinephrine Bitartrate; Tetracaine Hydrochloride; Lidocaine Hydrochloride
- Fentanyl Citrate
- Furosemide
- Hydromorphone Hydrochloride
- Ketamine Hydrochloride
- Lidocaine Hydrochloride
- Methadone Hydrochloride
- Midazolam
- Morphine Sulfate
- Phenylephrine Hydrochloride
- Potassium Chloride
- Rocuronium Bromide
- Ropivacaine Hydrochloride
- Sodium Chloride
- Succinylcholine Chloride
- Theophylline
Location
14135 E 42nd Ave Ste 50, Denver, CO 80239-5214
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: Mark Spiecker, 1-303-921-5789. 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 STAQ Pharma, Inc. with the Colorado State Board of Pharmacy.
503B facilities in Colorado
Colorado has 4 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Colorado.
Frequently asked questions
Is STAQ Pharma, Inc. registered with the FDA?
Yes. STAQ Pharma, Inc. is a registered 503B outsourcing facility, first registered with the FDA on February 5, 2019 and most recently registered on December 18, 2025.
Has STAQ Pharma, Inc. been inspected by the FDA?
The FDA last inspected STAQ Pharma, Inc. on February 10, 2025. No Form 483 was issued. FDA action on record: FMD-145 Letter Issued 6/6/2025.
Has STAQ Pharma, Inc. had any FDA drug recalls?
STAQ Pharma, Inc. has 6 FDA drug recalls on record (2022 to 2025) in the FDA enforcement database.
What does STAQ Pharma, Inc. compound?
STAQ Pharma, Inc. reports compounding 21 active ingredients to the FDA.
Where is STAQ Pharma, Inc. located?
STAQ Pharma, Inc. is located in Denver, Colorado (14135 E 42nd Ave Ste 50).
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 STAQ Pharma, 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.