BioSpectra Tris/Tromethamine, USP, GMP, API Grade Recall: Failed Stability (October 2026)
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BioSpectra, Inc. is recalling Biospectra Tris/Tromethamine, USP, GMP, API Grade because it failed stability specifications. The recall covers 200 kg. The FDA classed it as Class II. If you have the product, stop using it and check the official notice or contact BioSpectra, Inc.
Is my product affected?
The product is Biospectra Tris/Tromethamine, USP, GMP, API Grade. It was manufactured at 100 Majestic Way, Bangor, PA 18013. The NDC is 64173-101-25.
Check the lot number and expiration date against the identifiers listed below. The FDA recall number is D-0012-2027.
| Detail | Value |
|---|---|
| Brand | BioSpectra |
| Product | Biospectra Tris/Tromethamine, USP, GMP, API Grade |
| Units affected | 200 kg |
| FDA recall numbers | D-0012-2027 |
| Lot code | TRIS -E04-0226-0016 |
| Expiration date | 2/29/28 |
| NDC | 64173-101-25 |
What’s the hazard
The product failed stability specifications. The FDA classified the recall as Class II. This means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
What to do
Stop using the product and check the official notice or contact BioSpectra, Inc.
Contact: BioSpectra, Inc., Bangor, PA, United States.
The firm started the recall voluntarily on July 29, 2026. The recall is ongoing.
Where it was sold
The product was distributed in CA. The recall covers the United States.
Source
Source: U.S. Food and Drug Administration (FDA), event 99564.
From our recall records
This is the first BioSpectra recall in our records (we track FDA notices since October 2026). Regulators issued 17 Drugs recalls in the 30 days up to this notice. That counts every notice we received, not only the ones written up here.
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