OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

BioSpectra, Inc. recalls Biospectra Tris/Tromethamine

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
BioSpectra, Inc.
Reason
Failed stability specifications
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
CA
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99564…

Products

  1. Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25

    Codes/lots: Lot#: TRIS -E04-0226-0016; Exp 2/29/28Quantity: 200 kgRecall no. D-0012-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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