Biospectra Tris/Tromethamine recall (BioSpectra, Inc.)
DrugClass IIOngoing
Summary: BioSpectra, Inc. is recalling Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25. Reason: Failed stability specifications.
What is being recalled
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Why
Failed stability specifications
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
CA (states named: California)
How to tell if yours is affected
Lot#: TRIS -E04-0226-0016; Exp 2/29/28
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0012-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 29, 2026 |
| Reported | October 14, 2026 |
| Company | BioSpectra, Inc. |
| Company location | Bangor, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 200 kg |
More recalls from BioSpectra, Inc. · all drug recalls · recalls from July 2026