Every GLP-1 product BPI Labs LLC lists
One row per product NDC, in FDA’s words. Strength is printed as FDA lists it, spacing tidied.
| Product | Product NDC | Form and strength | FDA category | Listed | Packages |
|---|---|---|---|---|---|
| Semaglutide Injection, 1 mg/mLSemaglutide | 54288-826 | Injection · Subcutaneous1 mg/mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2024 report, first-half 2025 report | 1 package
|
| Semaglutide Injection, 12.5 mg/2.5 mL (5 mg/mL)Semaglutide | 54288-831 | Injection · Subcutaneous12.5 mg/2.5 mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2024 report, first-half 2025 report | 1 package
|
| Semaglutide Injection, 2.5mg/mL (1mL vial)Semaglutide | 54288-833 | Injection · Subcutaneous2.5 mg/mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | first-half 2025 report | 1 package
|
| Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL)Semaglutide | 54288-827 | Injection · Subcutaneous2.5 mg/mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2024 report, first-half 2025 report | 1 package
|
| Tirzepatide and Pyridoxine Hydrochloride Injection, 10 mg/mL and 10 mg/mLTirzepatide | 54288-841 | Injection · SubcutaneousPyridoxine Hydrochloride 10 mg/mL; Tirzepatide 10 mg/mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2025 report, first-half 2026 report | 1 package
|
| Tirzepatide and Pyridoxine Hydrochloride Injection, 20 mg/2 mL (10 mg/mL) and 20 mg/2 mL (10 mg/mL)Tirzepatide | 54288-859 | Injection · SubcutaneousPyridoxine Hydrochloride 20 mg/2 mL; Tirzepatide 20 mg/2 mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | first-half 2026 report | 1 package
|
| Tirzepatide and Pyridoxine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL) and 30 mg/3 mL (10 mg/mL)Tirzepatide | 54288-840 | Injection · SubcutaneousPyridoxine Hydrochloride 30 mg/3 mL; Tirzepatide 30 mg/3 mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2025 report, first-half 2026 report | 1 package
|
| Tirzepatide and Pyridoxine Hydrochloride Injection, 40 mg/4 mL (10 mg/mL) and 40 mg/4 mL (10 mg/mL)Tirzepatide | 54288-848 | Injection · SubcutaneousPyridoxine Hydrochloride 40 mg/4 mL; Tirzepatide 40 mg/4 mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2025 report, first-half 2026 report | 1 package
|
| Tirzepatide and Pyridoxine Hydrochloride Injection, 60 mg/3 mL (20 mg/mL) and 30 mg/3 mL (10 mg/mL)Tirzepatide | 54288-842 | Injection · SubcutaneousPyridoxine Hydrochloride 30 mg/3 mL; Tirzepatide 60 mg/3 mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2025 report, first-half 2026 report | 1 package
|
| Tirzepatide and Pyridoxine Hydrochloride Injection, 68 mg/4 mL (17 mg/mL) and 40 mg/4 mL (10 mg/mL)Tirzepatide | 54288-860 | Injection · SubcutaneousPyridoxine Hydrochloride 68 mg/4 mL; Tirzepatide 40 mg/4 mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | first-half 2026 report | 1 package
|
| Tirzepatide Injection, 10 mg/mLTirzepatide | 54288-835 | Injection · Subcutaneous10 mg/mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2024 report, first-half 2025 report | 1 package
|
| Tirzepatide Injection, 30 mg/3 mLTirzepatide | 54288-832 | Injection · Subcutaneous10 mg/mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2024 report, first-half 2025 report | 1 package
|
| Tirzepatide Injection, 60 mg/3 mLTirzepatide | 54288-836 | Injection · Subcutaneous20 mg/mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | second-half 2024 report, first-half 2025 report | 1 package
|
| Liraglutide Injection, 18 mg/3 mL (6 mg/mL)Liraglutide | 54288-846 | Injection · Subcutaneous18 mg/3 mL | 503B compoundedOUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS) | first-half 2026 report | 1 package
|
The rest of its federal record
Checked against every GLP-1 record we publish from FDA. A recall or shortage counts when FDA printed one of this firm’s NDCs in it; a letter or 503B entry counts when the firm name matches exactly. Similar names are listed apart and not counted.
503B outsourcing facility register
GLP-1 warning letters
None of the GLP-1 warning letters we hold is addressed to this name.
GLP-1 recalls
No GLP-1 recall in FDA’s enforcement reports matches this firm.
FDA enforcement reports, updated by FDA Sep 23, 2026. Every GLP-1 recall
FDA drug shortage list
None of this firm’s NDCs is on FDA’s GLP-1 shortage entries.
FDA drug shortages ↗, updated by FDA Oct 2, 2026.
What these listings mean, and what they do not
- 503B compounded. A drug a 503B outsourcing facility compounded and reported to FDA. FDA's own category name for these is "exempt from approval requirements": nobody has approved the product.
A listing is not an approval, and not a quality check. It tells FDA a firm makes, labels or compounds a drug. Whether a product was approved is a question about its application, shown above where there is one. Whether a plant passed inspection is a different record again.
The molecules. Semaglutide is the ingredient in Ozempic, Wegovy, Rybelsus; Tirzepatide is the ingredient in Mounjaro, Zepbound; Liraglutide is the ingredient in Victoza, Saxenda.
“Inclusion in the NDC Directory does not indicate that FDA has verified the information provided or that the products are FDA-approved.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗
“Assignment of an NDC number does not in any way denote FDA approval of the product.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗
“The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗
“Outsourcing facilities that have elected to assign NDCs to their products provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗
Related records
Other firms listing semaglutide, tirzepatide and liraglutide
FDA registers on this site
Sources
- FDA’s compounded drugs file ↗, last replaced by FDA .
- FDA’s National Drug Code Directory page ↗ for the quoted definitions.
- Read by us Oct 4, 2026. Not medical advice; this page describes filings, not products’ safety.