CLASS II ONGOING Drug recall · Reported 14 Oct 2026 · FDA Enforcement Report
Tris/Tromethamine, USP, GMP, API Grade recalled by BioSpectra
BioSpectra is recalling Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, distributed in California. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0012-2027
- FDA event ID
- 99564
- Recalling firm
- BioSpectra, Bangor, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2026
- FDA classified
- 6 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
Timeline
| 29 Jul 2026 | Recall initiated by company | |
| 6 Oct 2026 | Classified by FDA | +69 days |
| 14 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed stability specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25
Where it was distributed
CA
Questions about this recall
Why was it recalled?
Failed stability specifications
Which lots are affected?
Lot#: TRIS -E04-0226-0016; Exp 2/29/28
Where was it sold?
CA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.