Quality & complianceOfficial

FDA lists Class II recall of Biospectra tromethamine product over failed stability specifications

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Biospectra, Inc. is recalling its Tris/Tromethamine product after it failed stability specifications, according to an FDA enforcement report entry that lists the recall as ongoing.

The US Food and Drug Administration has classified a recall of Biospectra Tris/Tromethamine, made by Biospectra, Inc., as Class II. The entry, dated 14 October 2026, carries recall number D-0012-2027.

The stated reason is that the product failed stability specifications. The enforcement report lists the recall as ongoing, with distribution shown as CA.

The material available for this article does not say which stability parameter was out of specification or which lots are affected. It also gives no quantities, no dates for the initial recall and no information on how the problem was found. Those details would normally appear in the full enforcement report record.

By way of context, FDA assigns Class II to recalls where use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams using tromethamine-based materials from Biospectra should check the full FDA enforcement report record for lot and code information, as it is not in the summary.
  • A stability failure is a reminder to review shelf-life data, storage conditions and ongoing stability programmes for buffers and excipients from outside suppliers.
  • Regulatory and supply-chain teams should confirm whether any affected material reached their sites or customers, given the recall is still ongoing.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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