BioSpectra, Inc. recalls Biospectra Tris/Tromethamine
- Recalling company
- BioSpectra, Inc.
- Product
- Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
- Reason
- Failed stability specifications
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 29, 2026
- Reported
- Oct 14, 2026
- Distribution
- CA
- Status
- Ongoing
- Quantity
- 200 kg
- Lot / codes
- Lot#: TRIS -E04-0226-0016; Exp 2/29/28
- Company location
- Bangor, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0012-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0012-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.