Wells Pharma of Houston, LLC
FDA 503B outsourcing facility
Houston, Texas
Key Takeaways
- FDA-registered 503B outsourcing facility since 2020
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: April 13, 2026
- 8 FDA drug recalls on record (2023 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
- March 9, 2020
- Most recent registration
- December 3, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- April 13, 2026
The FDA last inspected Wells Pharma of Houston, LLC on April 13, 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
Wells Pharma of Houston, LLC has 8 FDA drug recalls on record between 2023 and 2026, based on the FDA enforcement database. Breakdown: 8 Class II.
Recall reasons on record include cgmp deviations; lack of assurance of sterility.
| Date | Class | Product | Reason |
|---|---|---|---|
| April 2026 | Class II | Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31. | cGMP deviations. |
| April 2026 | Class II | fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65. | cGMP deviations. |
| April 2026 | Class II | fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Hous | cGMP deviations. |
| April 2026 | Class II | fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02. | cGMP deviations. |
| April 2026 | Class II | fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25. | cGMP deviations. |
Showing the 5 most recent of 8 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
Wells Pharma of Houston, LLC reports compounding 20 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Semaglutide.
- Cefazolin
- Dextrose Monohydrate
- Ephedrine Sulfate
- Fentanyl
- Glycopyrrolate
- Indomethacin
- Ketamine
- Lidocaine
- Midazolam
- Morphine Sulfate
- Neostigmine Methylsulfate
- Nicotinamide Riboside Chloride
- Norepinephrine
- Phenylephrine Hydrochloride
- Rocuronium
- Ropivacaine Hydrochloride
- Ropivacaine Hydrochloride; Fentanyl
- Semaglutide
- Succinylcholine Chloride
- Vancomycin
Location
9265 Kirby Dr, Houston, TX 77054-2520
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Contact
FDA-registered contact: Carissa Imrecke, 1-346-888-1010. 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 Wells Pharma of Houston, LLC with the Texas State Board of Pharmacy.
503B facilities in Texas
Texas has 16 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Texas.
Frequently asked questions
Is Wells Pharma of Houston, LLC registered with the FDA?
Yes. Wells Pharma of Houston, LLC is a registered 503B outsourcing facility, first registered with the FDA on March 9, 2020 and most recently registered on December 3, 2025.
Has Wells Pharma of Houston, LLC been inspected by the FDA?
The FDA last inspected Wells Pharma of Houston, LLC on April 13, 2026. A Form FDA 483 was issued.
Has Wells Pharma of Houston, LLC had any FDA drug recalls?
Wells Pharma of Houston, LLC has 8 FDA drug recalls on record (2023 to 2026) in the FDA enforcement database.
What does Wells Pharma of Houston, LLC compound?
Wells Pharma of Houston, LLC reports compounding 20 active ingredients to the FDA, including Semaglutide.
Where is Wells Pharma of Houston, LLC located?
Wells Pharma of Houston, LLC is located in Houston, Texas (9265 Kirby 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 Wells Pharma of Houston, 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.