BioSpectra Tris/Tromethamine Recalled Due to Failed Stability Specifications

Key Takeaways:

• BioSpectra, Inc voluntarily initiated a recall of tris/tromethamine, USP, GMP, API Grade, which the US Food and Drug Administration (FDA) classified as Class II. The recall affects 200 kg of product from Lot TRIS-E04-0226-0016, which expires February 2028.
• BioSpectra initiated the recall after the product failed to meet stability specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• BioSpectra tris/tromethamine is used during pharmaceutical manufacturing as a buffer and excipient in downstream biological applications.

BioSpectra, Inc, based in Bangor, Pennsylvania, voluntarily initiated a recall affecting 200 kg of tris/tromethamine, USP, GMP, API Grade. This recall was initiated on July 29, 2026, and received a Class II classification by the FDA on October 6, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after the product failed to meet stability specifications. This issue affects Lot TRIS-E04-0226-0016, which will expire in February 2028. BioSpectra has sent out a public notice via telephone; no press release has been issued for this recall.

BioSpectra tris/tromethamine is a chemical used in pharmaceutical manufacturing, particularly as a buffer and excipient in downstream biological applications. Pharmacists should identify and quarantine Lot TRIS-E04-0226-0016, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 14, 2026. Accessed October 14, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221882