Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Trigen Laboratories, Inc. with 3 510(k) clearances and 2 drug recalls. The most recent is a drug recall dated Jun 17, 2024: Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 17, 2024 | Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, AClass II · Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specificatio | Drug recalls |
| Jul 25, 2012 | TL TRISEB CREAMK121134 · FRO | 510(k) clearances |
| Nov 18, 2011 | AVO BARRIER TOPICAL EMULSIONK110762 · FRO | 510(k) clearances |
| Aug 19, 2011 | TL-CERMIDE SKIN BARRIER EMULSIONK110757 · FRO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
