BioSpectra Recalls Tris/Tromethamine Due to Stability Failures
BioSpectra recalls 200 kg of Tris/Tromethamine, USP, GMP, API Grade due to failed stability specifications. Check lot TRIS-E04-0226-0016.
Recall notice
Failed stability specifications
What happened, in plain English
BioSpectra, Inc. is recalling a specific batch of its Tris/Tromethamine product because it failed stability specifications. The affected item is an API Grade substance manufactured in Bangor, PA. No further details on the remedy or distribution beyond California are provided in this record. Read more at govinfonow.com/recall/1623267-biospectra-inc-recalls-biospectra-tris-tromethamine-usp-gmp-api-grade.
Source Summary by GovInfoNow · govinfonow.com/recall/1623267-biospectra-inc-recalls-biospectra-tris-tromethamine-usp-gmp-api-grade · Published October 21, 2026 · Updated October 21, 2026 · FDA enforcement record: FDA #D-0012-2027
Cite this page
“BioSpectra Recalls Tris/Tromethamine Due to Stability Failures.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1623267-biospectra-inc-recalls-biospectra-tris-tromethamine-usp-gmp-api-grade. Based on FDA recall #D-0012-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0012-2027%22&limit=1).
Why it’s dangerous
The product failed stability specifications, which may affect its chemical integrity or potency. The specific health risks or consequences of using this unstable API are not described in the record.
Who’s affected
Entities in California that purchased BioSpectra's Tris/Tromethamine API Grade with lot number TRIS-E04-0226-0016 and expiration date of February 29, 2028.
How to tell if you have this one
Look for BioSpectra Tris/Tromethamine, USP, GMP, API Grade with NDC 64173-101-25. Specifically check for Lot number TRIS-E04-0226-0016 and an expiration date of 2/29/28.
- Brand
BioSpectra- Category
Drug
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “CA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0012-2027 (July 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0012-2027 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.