BioSpectra Tris/Tromethamine
Biospectra Tris/Tromethamine failed stability specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
BioSpectra, Inc. recalled 200 kg of BioSpectra Tris/Tromethamine, USP, GMP, API Grade, manufactured at 100 Majestic Way, Bangor, PA 18013, because it failed stability specifications. The company began the recall on July 29, 2026, and the FDA added it to the Enforcement Report on October 6, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Biospectra Tris/Tromethamine, USP, GMP, API Grade
- NDC
- 64173-101-25
- Lot
- E04-0226-0016
Details
- Company began the recall
- Event ID
- 99564
- Company
- BioSpectra, Inc.
- Hazard
- Failed specifications
- Quantity recalled
- 200 kg
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
